Preventing and Approaching Crises for Frail Community-dwelling Patients Through Through Innovative Care (PRACTIC)

NCT05651659 | Active Not Recruiting

• 1 other identifier: 150667
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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): RQ1: 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?

Conditions

Frailty

Keywords

frailty; crises; home care services; community-dwelling people; behavioural and psychological symptoms of dementia (BPSD); psychosocial interventions; case conferences

Outcome Measures

Primary Outcomes (1)

• Change in PGI (PRACTIC Goal-setting Interview) from baseline to 3 months

  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.

  Change from baseline at 3 months using the PGI (scale of 1-10)

Secondary Outcomes (17)

• Change in PGI (PRACTIC Goal-setting Interview)

  at 6 moths

• Change in symptoms (NPS)

  at 3 months

• Change in symptoms (NPS)

  at 6 months

• Change in quality of life measured

  at 3 months

• Change in quality of life measured

  at 6 moths

Study Arms (2)

Interventions municipalities

EXPERIMENTAL

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.

Other: TIME model in the prevention and treatment of crises in frail community-dwelling people

Control municipalities

NO INTERVENTION

Care as usual

Interventions

TIME model in the prevention and treatment of crises in frail community-dwelling people OTHER

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.

Interventions municipalities

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• in need of home care services
• a score ≥5 on the Clinical Frailty Scale (indicating mild to severe frailty)
• perceived by the home care service as being in an unstable situation with a high risk for acute institutionalisation or showing resistance to care.

You may not qualify if:

• \- expected short life expectancy (i.e., \<4 weeks).
• regular contact with the patient (i.e., at least once a week).

Sponsors & Collaborators

• Norwegian National Advisory Unit on Ageing and Health: collaborator
• Sykehuset Innlandet HF: lead
• Norwegian University of Science and Technology: collaborator
• Helse Stavanger HF: collaborator
• Hochschule für Gesundheit, University of Applied Sciences, Bochum, Germany: collaborator

Study Sites (1)

Sykehuset Innlandet

Ottestad, Norway, Norway

Location

Related Publications (3)

• 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: 41424838 DERIVED

• 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: 40437640 DERIVED

• 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.

  PMID: 38711048 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sverre Bergh, MD. PhD

  Sykehuset Innlandet HF

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial (RCT) with two parallel groups: intervention municipalities and control municipalities

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: January 7, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified individual participant data and supporting documents are available from 6 December 2024 and will remain available until 1 April 2031.
• Access Criteria: 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.

Locations

NO (1)