Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:23 PM
Study NCT ID:
NCT00877058
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2009-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
SUPPORT FOR FRAIL ELDERLY PERSONS - From Prevention to Palliation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'synneve.dahlin-ivanoff@gu.se', 'phone': '+46317865733', 'title': 'Professor Synneve Dahlin-Ivanoff (Research leader)', 'organization': 'Göteborg University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 Preventive Home Visits', 'description': 'This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.', 'otherNumAtRisk': 174, 'otherNumAffected': 0, 'seriousNumAtRisk': 174, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 Senior Meetings', 'description': "The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.", 'otherNumAtRisk': 171, 'otherNumAffected': 0, 'seriousNumAtRisk': 171, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3 Control Group', 'description': 'The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.', 'otherNumAtRisk': 114, 'otherNumAffected': 0, 'seriousNumAtRisk': 114, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dependence in Two or More Activities of Daily Living (ADL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 Preventive Home Visits', 'description': 'This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.'}, {'id': 'OG001', 'title': '2 Senior Meetings', 'description': "The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf."}, {'id': 'OG002', 'title': '3 Control Group', 'description': 'The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.48', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '0.05', 'paramValue': '0.40', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.68', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'ADL stair case:\n\nIndependence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0-9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Partipants Measured Frail at 1-year Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 Preventive Home Visits', 'description': 'This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.'}, {'id': 'OG001', 'title': '2 Senior Meetings', 'description': "The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf."}, {'id': 'OG002', 'title': '3 Control Group', 'description': 'The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '0.96', 'ciUpperLimit': '2.52', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.08', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT was used. The basic assumption was that older adults (80+) deteriorate over time in the natural course of the aging process. The imputation method chosen was to replace missing values with a value based on the Median Change of Deterioration (MCD) a conservative form of worst case between baseline and follow-up.'}, {'type': 'PRIMARY', 'title': 'Self Rated Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 Preventive Home Visits', 'description': 'This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.'}, {'id': 'OG001', 'title': '2 Senior Meetings', 'description': "The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf."}, {'id': 'OG002', 'title': '3 Control Group', 'description': 'The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.31', 'ciUpperLimit': '0.97', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.02', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Self rated health was measured by the question "In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Preventive Home Visits', 'description': 'This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.'}, {'id': 'FG001', 'title': '2 Senior Meetings', 'description': "The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings. http://www.vardalinstitutet.net/livslots.pdf."}, {'id': 'FG002', 'title': '3 Control Group', 'description': 'The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '171'}, {'groupId': 'FG002', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '39'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '459', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1 Preventive Home Visits', 'description': 'This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.'}, {'id': 'BG001', 'title': '2 Senior Meetings', 'description': "The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf."}, {'id': 'BG002', 'title': '3 Control Group', 'description': 'The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '459', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': '≥80 years', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000', 'lowerLimit': '80', 'upperLimit': '97'}, {'value': '85', 'groupId': 'BG001', 'lowerLimit': '80', 'upperLimit': '94'}, {'value': '86', 'groupId': 'BG002', 'lowerLimit': '80', 'upperLimit': '97'}, {'value': '86', 'groupId': 'BG003', 'lowerLimit': '80', 'upperLimit': '97'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '294', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '459', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 459}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-11', 'studyFirstSubmitDate': '2009-04-06', 'resultsFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-11', 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dependence in Two or More Activities of Daily Living (ADL)', 'timeFrame': '1 year', 'description': 'ADL stair case:\n\nIndependence of, or dependence on, another person in ADL was assessed according to a cumulative scale of well-defined personal and instrumental activities, the ADL staircase. Nine out of the ten original activities were used; Cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transfer, and feeding (0-9). Dependence was defined as another person being involved in the activity by giving personal or directive assistance. People living together were assessed as independent if they performed the activity when alone. The number of partipants with dependence in two or more ADL at follow-up have been analyzed'}, {'measure': 'Number of Partipants Measured Frail at 1-year Follow up', 'timeFrame': '1 year', 'description': 'Frailty defined as a sum of weakness, fatigue, weight loss, low physical activity, poor balance, slow gait speed, visual impairment and impaired cognition'}, {'measure': 'Self Rated Health', 'timeFrame': '1 year', 'description': 'Self rated health was measured by the question "In general would yoy say your health is: excellent, very good, good, fair or poor? Number of participants detoriated in self-rated health has been analysed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Frailty', 'health promotion', 'prevention', 'self management', 'intervention'], 'conditions': ['Frail Elderly Persons']}, 'referencesModule': {'references': [{'pmid': '39360568', 'type': 'DERIVED', 'citation': 'Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.'}, {'pmid': '27716095', 'type': 'DERIVED', 'citation': 'Dahlin-Ivanoff S, Eklund K, Wilhelmson K, Behm L, Haggblom-Kronlof G, Ziden L, Landahl S, Gustafsson S. For whom is a health-promoting intervention effective? Predictive factors for performing activities of daily living independently. BMC Geriatr. 2016 Oct 6;16(1):171. doi: 10.1186/s12877-016-0345-8.'}, {'pmid': '20504358', 'type': 'DERIVED', 'citation': 'Dahlin-Ivanoff S, Gosman-Hedstrom G, Edberg AK, Wilhelmson K, Eklund K, Duner A, Ziden L, Welmer AK, Landahl S. Elderly persons in the risk zone. Design of a multidimensional, health-promoting, randomised three-armed controlled trial for "prefrail" people of 80+ years living at home. BMC Geriatr. 2010 May 26;10:27. doi: 10.1186/1471-2318-10-27.'}]}, 'descriptionModule': {'briefSummary': 'The present study "Elderly person in the risk zone" form part of the research programme "Support for frail elderly persons - from prevention to palliation" (www. Vardalinstitutet.net) which comprises research into three interventions. A fundamental principle in the research programme is that it comprises interventions addressing frail elderly person in different phases of the disablement process, from elderly persons who are beginning to develop frailty to very frail elderly persons receiving palliative care in the final period of their lives. The interventions also address the different requirements that arise with regard to professional contributions during the various phases of the ageing and disease process, ranging from health promotion to a need for an increasing degree of medical care, nursing, special care and rehabilitation, and finally, efforts that promote symptom relief, quality of life, security and satisfaction with care during the final period of life. The intervention "Elderly persons in the risk zone" addresses elderly persons that are on the point of developing frailty ("pre-frail") and are beginning to feel that they are being hindered from taking part in everyday activities. The hypothesis is that if an intervention is made when the persons are not so frail, it is possible to prevent/delay deterioration.\n\n1. Can a health-promoting and preventive intervention for "prefrail" elderly persons:\n\n * prevent frailty, activity limitations and morbidity,\n * be a supportive factor in the social and physical environment,\n * affect life satisfaction\n * have an impact on the consumption of care\n * be cost-effective?\n2. How do the frail elderly persons experience the intervention and its importance to health?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 80 years of age or older living in the community.\n* The participants should live in their ordinary housing\n* Independent on formal support\n* Independent on informal support\n* Cognitive intact defined as a Mini Mental Test score \\> 25'}, 'identificationModule': {'nctId': 'NCT00877058', 'briefTitle': 'SUPPORT FOR FRAIL ELDERLY PERSONS - From Prevention to Palliation', 'organization': {'class': 'OTHER', 'fullName': 'Vardalinstitutet The Swedish Institute for Health Sciences'}, 'officialTitle': 'Elderly Persons at the Risk Zone - a Randomized Controlled Trial of a Community Based Preventive Multiprofessional Program for Old Persons at Risk of Frailty', 'orgStudyIdInfo': {'id': 'G213 194/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.Preventive home visit', 'description': 'Preventive home visits: This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.', 'interventionNames': ['Behavioral: preventive home visit']}, {'type': 'EXPERIMENTAL', 'label': '2. Senior meetings', 'description': 'The senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging.', 'interventionNames': ['Behavioral: senior meetings']}, {'type': 'NO_INTERVENTION', 'label': '3. Control group', 'description': 'The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.'}], 'interventions': [{'name': 'preventive home visit', 'type': 'BEHAVIORAL', 'armGroupLabels': ['1.Preventive home visit']}, {'name': 'senior meetings', 'type': 'BEHAVIORAL', 'armGroupLabels': ['2. Senior meetings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '416 56', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Gothenburg University', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Synneve Dahlin Ivanoff, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vardalinstitutet The Swedish Institute for Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Synneve Dahlin Ivanoff', 'investigatorAffiliation': 'Göteborg University'}}}}