Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-08 @ 4:47 AM
Study NCT ID:
NCT03240094
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2017-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Effectiveness of Nutritional Telemonitoring in Community-dwelling Elderly.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2017-07-24', 'studyFirstSubmitQcDate': '2017-08-03', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutritional status (MNA)', 'timeFrame': '6 months', 'description': 'Measured by Mini Nutritional Assessment'}], 'secondaryOutcomes': [{'measure': 'Behavioural determinant: Knowledge', 'timeFrame': '6 months', 'description': "Measured with 11 knowledge statements to be answered by true/false/don't know"}, {'measure': 'Behavioural determinant: Goalsetting', 'timeFrame': '6 months', 'description': 'Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.'}, {'measure': 'Behavioural determinant: Intention to eat healthy', 'timeFrame': '6 months', 'description': 'Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.'}, {'measure': 'Behavioural determinant: Intention to improve physical activity', 'timeFrame': '6 months', 'description': 'Measured by three items to be answered on a 5 point likert scale on a 5-point likert scale.'}, {'measure': 'Behavioural determinant: Self efficacy', 'timeFrame': '6 months', 'description': 'Measured by two items to be answered on a 5 point likert scale on a 5-point likert scale.'}, {'measure': 'Behavioural determinant: Perceived behavioural control', 'timeFrame': '6 months', 'description': 'Measured by five items to be answered on a 5 point likert scale on a 5-point likert scale.'}, {'measure': 'Behavioural determinants: Attitude', 'timeFrame': '6 months', 'description': 'Measured by 14 items to be answered on a 5 point likert scale'}, {'measure': 'Diet quality (DHD-index)', 'timeFrame': '6 months', 'description': 'Measured by Dutch Healthy Diet index (DHD-index)'}, {'measure': 'Appetite (SNAQ)', 'timeFrame': '6 months', 'description': 'Measured by Simplified Nutritional Appetite Questionnaire'}, {'measure': 'Body weight (kg)', 'timeFrame': '6 months', 'description': 'Measured by weighing scale of the brand A\\&D, type UC-411PBT-C'}, {'measure': 'Physical functioning (SPPB)', 'timeFrame': '6 months', 'description': 'Measured by Short Physical Performance Battery (SPPB)'}, {'measure': 'Functional status (KATZ-15)', 'timeFrame': '6 months', 'description': 'Measured by KATZ-15'}, {'measure': 'Quality of life (SF-36)', 'timeFrame': '6 months', 'description': 'Measured by Short-Form 36'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ehealth', 'Older adults', 'Undernutrition'], 'conditions': ['Undernutrition', 'Aging']}, 'referencesModule': {'references': [{'pmid': '30445922', 'type': 'DERIVED', 'citation': 'van Doorn-van Atten MN, Haveman-Nies A, Pilichowski P, Roca R, de Vries JHM, de Groot CPGM. Telemonitoring to improve nutritional status in community-dwelling elderly: design and methods for process and effect evaluation of a non-randomized controlled trial. BMC Geriatr. 2018 Nov 16;18(1):284. doi: 10.1186/s12877-018-0973-2.'}, {'pmid': '29759110', 'type': 'DERIVED', 'citation': 'van Doorn-van Atten MN, Haveman-Nies A, van Bakel MM, Ferry M, Franco M, de Groot LCPGM, de Vries JHM. Effects of a multi-component nutritional telemonitoring intervention on nutritional status, diet quality, physical functioning and quality of life of community-dwelling older adults. Br J Nutr. 2018 May;119(10):1185-1194. doi: 10.1017/S0007114518000843.'}]}, 'descriptionModule': {'briefSummary': 'An optimal nutritional status is essential for healthy ageing. Telemonitoring might contribute to maintaining or improving nutritional status in elderly people.The objectives of this effect study are to test the feasibility and effectiveness of telemonitoring of nutritional parameters in community-dwelling older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHaving a care referral for at least one of the following types of care:\n\n* Domestic care\n* Personal care\n* Nursing care\n* Individual or group support\n* Living in a sheltered home or service flat\n\nExclusion Criteria:\n\n* Severe cognitive impairment (Mini Mental State Examination (MMSE) \\< 20)\n* Receiving terminal care\n* Not having a television at home\n* Clients with a visual impairment (not able to watch the television screen)\n* Clients with a physical impairment in such a way, that they are not able to use the telemonitoring system\n* Clients with nursing home care'}, 'identificationModule': {'nctId': 'NCT03240094', 'briefTitle': 'Feasibility and Effectiveness of Nutritional Telemonitoring in Community-dwelling Elderly.', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'PhysioDom Home Dietary Intake Monitoring: Telemonitoring of Nutritional Parameters and Other Outcomes in Community Dwelling Elderly People: a Process and Effect Study.', 'orgStudyIdInfo': {'id': 'NL53619.081.15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional telemonitoring', 'description': 'Participants in the intervention group receive a telemonitoring intervention, including self-measurements of body weight, nutritional status, appetite, diet quality, and physical activity. Additionally, participants receive guidance on nutrition and physical activity by means of customized and general television messages and/or if necessary personal guidance by a nurse.', 'interventionNames': ['Other: Nutritional telemonitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Participants in the control group receive usual care.'}], 'interventions': [{'name': 'Nutritional telemonitoring', 'type': 'OTHER', 'description': 'Participants receive a weighing scale, pedometer and television channel in order to perform self measurements and receive guidance on nutrition and physical activity. Nurses use a website in order to receive telemonitoring measurements and decide about proper follow-up. In case of risk of undernutrition, nurses provide personal advice to optimize nutritional status of the participant.', 'armGroupLabels': ['Nutritional telemonitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700AA', 'city': 'Wageningen', 'country': 'Netherlands', 'facility': 'Wageningen University & Research', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Lisette de Groot, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Wageningen University & Research'}, {'name': 'Marije van Doorn, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University & Research'}, {'name': 'Jeanne de Vries, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University & Research'}, {'name': 'Annemien Haveman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University & Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Union', 'class': 'OTHER'}, {'name': 'Consorci Sanitari de Terrassa', 'class': 'OTHER'}, {'name': 'Viveris Technologies SA', 'class': 'UNKNOWN'}, {'name': 'STMicroelectronics Grenoble 2 SAS', 'class': 'UNKNOWN'}, {'name': 'Sirlan Technologies SAS', 'class': 'UNKNOWN'}, {'name': 'Habitat Health Environment', 'class': 'OTHER'}, {'name': 'Universite Paris 13', 'class': 'UNKNOWN'}, {'name': 'Meditecnologia SA', 'class': 'UNKNOWN'}, {'name': 'Cybermoor Ltd', 'class': 'OTHER'}, {'name': 'Telecom Sante', 'class': 'UNKNOWN'}, {'name': 'Zorggroep Noordwest-Veluwe', 'class': 'OTHER'}, {'name': 'Opella', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}