Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-27 @ 1:46 AM
Study NCT ID:
NCT05651659
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-26
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing and Approaching Crises for Frail Community-dwelling Patients Through Through Innovative Care (PRACTIC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-27', 'size': 1128088, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-08T04:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Specially trained nurses (data assessors) from the project's research centre who are not affiliated with the municipalities will, together with staff members in the home care services, assess patients' baseline characteristics before randomisation. These data assessors will after randomisation be blinded to the randomisation result. They will assess the effect of the intervention via telephone by interviewing the participants, the next of kin and the staff members who know the patient best, at three months and six months after baseline assessments."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomized controlled trial (RCT) with two parallel groups: intervention municipalities and control municipalities'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months', 'timeFrame': 'Change from baseline at 3 months using the PGI (scale of 1-10)', 'description': 'The primary outcome of the trial is the difference in the change between intervention and control group in individual goal achievement to resolve or reduce the challenges of the crises.'}], 'secondaryOutcomes': [{'measure': 'Change in PGI (PRACTIC Goal-setting Interview)', 'timeFrame': 'at 6 moths', 'description': 'the differences in the change between intervention and control group in the BGSI scale at 6 months, in neuropsychiatric symptoms'}, {'measure': 'Change in symptoms (NPS)', 'timeFrame': 'at 3 months', 'description': 'Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144.'}, {'measure': 'Change in symptoms (NPS)', 'timeFrame': 'at 6 months', 'description': 'Neuropsychiatric symptoms (NPS) measured by the Neuropsychiatric Inventory (NPI-NH). Score for each symptom: 0-12 points. Total score 144'}, {'measure': 'Change in quality of life measured', 'timeFrame': 'at 3 months', 'description': 'Quality of life measured by the Quality of Life in Late Stage Dementia scale (QUALID). The score will remain between 11 and 55, with 11 representing the highest quality of life.'}, {'measure': 'Change in quality of life measured', 'timeFrame': 'at 6 moths', 'description': 'Quality of life measured by the Quality of Life in Late Stage Dementia scale (QUALID).The score will remain between 11 and 55, with 11 representing the highest quality of life.'}, {'measure': 'Change in distress perceived by the next of kin', 'timeFrame': 'at 3 months', 'description': 'Distress perceived by the next of kin measured by the Relative Stress Scale (RSS). Total score between 0-60, higher score in an area, more likely higher relative stress.'}, {'measure': 'Change in distress perceived by the next of kin', 'timeFrame': 'at 6 months', 'description': 'Distress perceived by the next of kin measured by the Relative Stress Scale (RSS). Total score between 0-60, higher score in an area, more likely higher relative stress.'}, {'measure': 'Change in rejection of care', 'timeFrame': 'at 3 months', 'description': 'Rejection of care - Minimal Data Set (MDS)'}, {'measure': 'Change in rejection of care', 'timeFrame': 'at 6 months', 'description': 'Rejection of care - Minimal Data Set (MDS)'}, {'measure': 'Change at Activities of Daily Living', 'timeFrame': 'at 3 months', 'description': 'Activities of Daily Living - assessed with the Physical Self-Maintenance Scale (PSMS). Total score between 0-30, higher score in an area, more likely that the patient may be in need of help in that area.'}, {'measure': 'Change at Activities of Daily Living', 'timeFrame': 'at 6 months', 'description': 'Activities of Daily Living - assessed with the Physical Self-Maintenance Scale (PSMS).\n\nTotal score between 0-30, higher score in an area, more likely that the patient may be in need of help in that area.'}, {'measure': 'Change in medication from medical records', 'timeFrame': 'at 3 months', 'description': 'Medication from medical records'}, {'measure': 'Change in medication from medical records', 'timeFrame': 'at 6 months', 'description': 'Medication from medical records'}, {'measure': 'Institutionalization', 'timeFrame': 'at 3 months', 'description': 'Change in level of care'}, {'measure': 'Institutionalization', 'timeFrame': 'at 6 months', 'description': 'Change in level of care'}, {'measure': 'Clinical Frailty scale', 'timeFrame': '6 months', 'description': 'Frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).'}, {'measure': 'EQ-5D questionnaire', 'timeFrame': '6 months', 'description': 'The EQ-5D questionnaire to evaluate pain and discomfort. The dimension pain/discomfort has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['frailty', 'crises', 'home care services', 'community-dwelling people', 'behavioural and psychological symptoms of dementia (BPSD)', 'psychosocial interventions', 'case conferences'], 'conditions': ['Frailty']}, 'referencesModule': {'references': [{'pmid': '41424838', 'type': 'DERIVED', 'citation': 'Vaeringstad A, Kirkevold O, Dalbak ETG, Myhre J, Feiring IH, Bergh S, Lichtwarck B. Development of the PRACTIC Goal Setting Interview (PGSI) for Frail Community-Dwelling Patients. Feasibility, Interrater Reliability and Content validity-a Mixed Methods Study. Patient Prefer Adherence. 2025 Dec 12;19:4033-4050. doi: 10.2147/PPA.S557233. eCollection 2025.'}, {'pmid': '40437640', 'type': 'DERIVED', 'citation': 'Dalbak ETG, Vaeringstad A, Lichtwarck B, Myhre J, Holle D, Bergh S, Kirkevold O. Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC): study protocol for a process evaluation of a complex intervention in home care service. Trials. 2025 May 28;26(1):178. doi: 10.1186/s13063-025-08876-w.'}, {'pmid': '38711048', 'type': 'DERIVED', 'citation': 'Vaeringstad A, Dalbak ETG, Holle D, Myhre J, Kirkevold O, Bergh S, Lichtwarck B. PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC): protocol for an effectiveness cluster randomised controlled trial. Trials. 2024 May 6;25(1):304. doi: 10.1186/s13063-024-08117-6.'}]}, 'descriptionModule': {'briefSummary': 'Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC). Participatory action research in a cluster randomised controlled trial. The primary purpose of this study is to test the effectiveness of an adapted version of a bio-psychosocial person centred model (TIME) to prevent and resolve crises for frail community-dwelling people receiving home care services. The investigators have formulated the following research questions (RQ):\n\nRQ1: Can the TIME model adapted for home care service, prevent, and resolve crises in frail people receiving home care services? RQ2: Which participant characteristics or organizational factors are associated with the effect of the TIME model? RQ3: What are the experiences of the users of home care services on how crises were approached during the trial?', 'detailedDescription': "This study is part of the larger PRACTIC (Preventing and approaching crises for frail community-dwelling patients through innovative care) study. This is a six-month cluster randomized controlled trial (RCT). The trial will be conducted in 30 municipalities including 150 frail community-dwelling participants receiving homecare services judged by the services to have imminent crises. The proposed sample of 150 participants is based on a power calculation with clusters of approximately 5 participants from each of the 30 municipalities. Each municipality will be defined as a cluster and will be randomized to receive either the locally adapted TIME intervention (the intervention group) or care as usual (the control group). TIME is a manual-based, multicomponent programme that will include a rigorous assessment of the crises, one or more interdisciplinary case conferences and the testing and evaluation of customised treatment measures. For the interviews in RQ3, the investigators will use a purposeful sample of approximately 15 dyads with 15 patients and next of kin from the intervention municipalities in the RCT\n\nSpecially trained nurses (data assessors) from the project's research centre who are not affiliated with the municipalities will, together with staff members in the home care services, assess patients' baseline characteristics before randomisation. The data assessors will assess the effect of the intervention via telephone by interviewing the participants, the next of kin and the staff members who know the patient best, at three months and six months after baseline assessments. The interviews will based on a semi-structured interview guide where the participants will be asked to reflect on two main themes.\n\nTo evaluate the effects of a bio-psychosocial intervention like TIME to prevent and resolve crises in a heterogenous population, there is a need for a goal-oriented outcome compromising this variability. The goal of the intervention and the outcome will necessarily vary from patient to patient. The investigators will therefore use a individual goal-oriented interview, the PRACTIC goal-setting interview (PGI), based on The Bangor Goalsetting Interview, BGSI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n1. in need of home care services\n2. a score ≥5 on the Clinical Frailty Scale (indicating mild to severe frailty)\n3. perceived by the home care service as being in an unstable situation with a high risk for acute institutionalisation or showing resistance to care.\n\nExclusion Criteria for patients:\n\n\\- expected short life expectancy (i.e., \\<4 weeks).\n\nInclusion criteria for next of kin (for RQ3):\n\n1. being next of kin of a user of home care services who meets the above mentioned inclusion criteria\n2. regular contact with the patient (i.e., at least once a week).'}, 'identificationModule': {'nctId': 'NCT05651659', 'acronym': 'PRACTIC', 'briefTitle': 'Preventing and Approaching Crises for Frail Community-dwelling Patients Through Through Innovative Care (PRACTIC)', 'organization': {'class': 'OTHER', 'fullName': 'Sykehuset Innlandet HF'}, 'officialTitle': 'Preventing and Approaching Crises for Frail Community-dwelling Patients Through Innovative Care (PRACTIC) - an Effectiveness Study', 'orgStudyIdInfo': {'id': '150667'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventions municipalities', 'description': 'Locally adapted TIME (Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms) intervention. Municipalities will be randomly assigned to either the intervention group or the control group. A biostatician will perform the randomisation procedure independently of the project management team and the municipalities. The project management team will provide the home care services in the municipalities with the randomisation and allocation results immediately following this procedure. The intervention will start with the educational sessions (described below) within one to two weeks after randomisation.', 'interventionNames': ['Other: TIME model in the prevention and treatment of crises in frail community-dwelling people']}, {'type': 'NO_INTERVENTION', 'label': 'Control municipalities', 'description': 'Care as usual'}], 'interventions': [{'name': 'TIME model in the prevention and treatment of crises in frail community-dwelling people', 'type': 'OTHER', 'description': 'TIME is a manual-based, multicomponent programme that will include a rigorous assessment of the crises, one or more interdisciplinary case conferences and the testing and evaluation of customised treatment measures.This multicomponent interdisciplinary model consisting of three overlapping phases. First the assessment phase where the care staff and the physician collaborate in a comprehensive bio-psychosocial assessment. The second phase is the reflection phase with interdisciplinary case conferences based on principles from cognitive behavioural therapy and abc-method, where a customized treatment plan is developed. The abc-method from cognitive behavioural therapy is used as an analytic tool for the analyses of the complex challenges in the case conferences. In the third phase the treatment plan is implemented and evaluated systematically.', 'armGroupLabels': ['Interventions municipalities']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ottestad', 'state': 'Norway', 'country': 'Norway', 'facility': 'Sykehuset Innlandet', 'geoPoint': {'lat': 60.74743, 'lon': 11.1366}}], 'overallOfficials': [{'name': 'Sverre Bergh, MD. PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sykehuset Innlandet HF'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'De-identified individual participant data and supporting documents are available from 6 December 2024 and will remain available until 1 April 2031.', 'ipdSharing': 'YES', 'description': 'Collaborating partners in the study will not have access to the individual participant data. The data collected in the study are not publicly available. De-identified participant data will be made available upon reasonable request to the members of the research team at the Research Centre for Age-related Functional Decline and Disease (AFS), Innlandet Hospital Trust.', 'accessCriteria': 'De-identified participant data will be made available upon reasonable request from reseachers to the members of the research team at the Research Centre for Age-related Functional Decline and Disease (AFS), Innlandet Hospital Trust.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Innlandet HF', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'The Norwegian National Advisory Unit on Ageing and Health', 'class': 'UNKNOWN'}, {'name': 'Helse Stavanger HF', 'class': 'OTHER_GOV'}, {'name': 'Hochschule für Gesundheit, University of Applied Sciences, Bochum, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}