The Effects of Integrated Face-to-face Rehabilitation and Telerehabilitation on the Well-being of Family Caregivers

Caregivers Clinical Trial

Official title:

The Effects of Integrated Face-to-face Rehabilitation and Telerehabilitation on the Well-being of Family Caregivers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05678946
• Other study ID #: SocialII
• Status: Active, not recruiting
• Start date: April 11, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Social Insurance Institution, Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Caregivers
• Family Caregivers
• Informal Caregivers

Intervention

Other:
• Integrated face-to-face rehabilitation and telerehabilitation
Kela´s integrated face-to-face rehabilitation and telerehabilitation services for family caregivers include two 5-day periods of face-to-face rehabilitation and a 12-week telerehabilitation period between them. It is for those over the age of 18 who work as family caregivers on a daily basis and need support, tools, and coaching to understand and overcome the challenges posed by the care situation. Individual goals based on the GAS method are set, evaluated, and adjusted during the rehabilitation. The service, provided free of charge, is carried out in a Finnish rehabilitation centre and online over a period of 8 months, and it is implemented by a multidisciplinary team of rehabilitation experts. During the 12-week telerehabilitation period, the service providers utilise The Own Path, an acceptance and commitment therapy -based guided web intervention found beneficial for older Finnish family caregivers (Lappalainen et al. 2021). Telerehabilitation is independent of time and place.
• Social Holidays
MTLH's Social Holidays for family caregivers are 5-day holidays in a Finnish hotel, spa, sports institute, or rehabilitation centre. The theme, content, and level of available assistance in Social Holidays vary, and the rehabilitation concept is lighter than that of Kela's rehabilitation services. Social Holidays include full-board accommodation and holiday activities, e.g. lectures, group discussions, instructed exercise, and a pampering treatment. MTLH organises Social Holidays for family caregivers as well as family caregivers and care recipients. The participants cover their travel expenses and pay a fixed sum of €125. Other than that, Social Holidays are provided free of charge. Social Holidays are intended for family caregivers who need recreational activities, rest, and peer support.
• Face-to-face rehabilitation
Kela's rehabilitation services for family caregivers and the care recipients include three 5-day periods of face-to-face rehabilitation, which are carried out in a Finnish rehabilitation centre over a 10-month period and implemented by a multidisciplinary team of rehabilitation experts. The rehabilitation services for family caregivers and the care recipients are provided free of charge. The service is intended for persons over the age of 18 who work as family caregivers on a daily basis with or without family caregiver support and who need support, tools, and coaching to understand and overcome the challenges posed by the care situation. Individual goals based on the GAS method are set, evaluated, and adjusted during the rehabilitation.

Locations

Country	Name	City	State
Finland	The Social Insurance Institution of Finlad	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Social Insurance Institution, Finland

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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

Outcome

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)