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

Sponsor
Social Insurance Institution, Finland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05678946
Collaborator
(none)
180
1
17.6
10.2

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Integrated face-to-face rehabilitation and telerehabilitation
  • Other: Social Holidays
  • Other: Face-to-face rehabilitation

Study Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Integrated Face-to-face Rehabilitation and Telerehabilitation on the Well-being of Family Caregivers
Actual Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Integrated face-to-face rehabilitation and telerehabilitation

Participation in integrated face-to-face rehabilitation and telerehabilitation services for family caregivers organized by the Social Insurance Institution of Finland (Kela)

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

Participation in face-to-face Social Holidays for family caregivers organized by Maaseudun Terveys- ja Lomahuolto (MTLH), a non-profit organization

Other: 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

Participation in face-to-face rehabilitation services for family caregivers and the care recipients organized by Kela

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in mood at 5 months and 8 months [Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)]

    assessed with the Beck's Depression Inventory (BDI-21)

Secondary Outcome Measures

  1. Change from baseline in Quality of life (QoL) at 5 months and 8 months [Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)]

    assessed with the World Health Organization Quality of Life Instrument (WHOQOL-BREF)

  2. Change from baseline in perceived burden of family care (I) at 5 months and 8 months [Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)]

    assessed with the Carers of Older People in Europe (COPE) index

  3. Change from baseline in perceived burden of family care (II) at 5 months and 8 months [Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)]

    assessed with the Adult Social Care Outcomes Toolkit (ASCOT) questionnaire

  4. Change from baseline in overall health at 5 months and 8 months [Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)]

    assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) survey

  5. Individual goal achievement [5 months (after the intervention)]

    assessed with the Goal Attainment Scaling method (GAS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Social Insurance Institution of Finlad Helsinki Finland 00250

Sponsors and Collaborators

  • Social Insurance Institution, Finland

Investigators

  • Principal Investigator: Saija Karinkanta, PhD, The Social Insurance Institution of Finland (Kela)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Social Insurance Institution, Finland
ClinicalTrials.gov Identifier:
NCT05678946
Other Study ID Numbers:
  • SocialII
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 12, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Social Insurance Institution, Finland

Study Results

No Results Posted as of Jan 12, 2023