Caregivers Clinical Trial
Official title:
The Effects of Integrated Face-to-face Rehabilitation and Telerehabilitation on the Well-being of Family Caregivers
Verified date | February 2023 |
Source | Social Insurance Institution, Finland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This controlled, non-randomized study (n=180) explores how participating in rehabilitation services for family caregivers affects the caregivers' mood, perceived quality of life, perceived burden of family care, and overall health. Rehabilitation services for family caregivers funded by the Social Insurance Institution of Finland (Kela) include two 5-day periods of face-to-face rehabilitation and a 12-week telerehabilitation period, which is based on The Own Path internet intervention and takes place between the face-to-face rehabilitation periods. The observed changes are compared to participating in two other services: 1) Social Holidays for family caregivers and 2) Kela's rehabilitation services for family caregivers and the family members they are caring for (care recipients).
Status | Active, not recruiting |
Enrollment | 195 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - family caregiver - being 18 years of age or older - providing daily care for an adult family member - participating in one of following: 1. the Kela's integrated face-to-face rehabilitation and telerehabilitation service for family caregivers, 2. the MTLH's face-to-face Social Holidays for family caregivers or 3. the Kela's face-to-face rehabilitation services for family caregivers and care recipients - willingness to participate in the study |
Country | Name | City | State |
---|---|---|---|
Finland | The Social Insurance Institution of Finlad | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Social Insurance Institution, Finland |
Finland,
Lappalainen P, Pakkala I, Lappalainen R, Nikander R. Supported Web-Based Acceptance and Commitment Therapy for Older Family Caregivers (CareACT) Compared to Usual Care. Clin Gerontol. 2022 Jul-Sep;45(4):939-955. doi: 10.1080/07317115.2021.1912239. Epub 2021 Apr 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in mood at 5 months and 8 months | assessed with the Beck's Depression Inventory (BDI-21) | Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up) | |
Secondary | Change from baseline in Quality of life (QoL) at 5 months and 8 months | assessed with the World Health Organization Quality of Life Instrument (WHOQOL-BREF) | Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up) | |
Secondary | Change from baseline in perceived burden of family care (I) at 5 months and 8 months | assessed with the Carers of Older People in Europe (COPE) index | Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up) | |
Secondary | Change from baseline in perceived burden of family care (II) at 5 months and 8 months | assessed with the Adult Social Care Outcomes Toolkit (ASCOT) questionnaire | Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up) | |
Secondary | Change from baseline in overall health at 5 months and 8 months | assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) survey | Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up) | |
Secondary | Individual goal achievement | assessed with the Goal Attainment Scaling method (GAS) | 5 months (after the intervention) |
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