- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05678946
The Effects of Integrated Face-to-face Rehabilitation and Telerehabilitation on the Well-being of Family Caregivers
November 29, 2024 updated by: Social Insurance Institution, Finland
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).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
195
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Helsinki, Finland, 00250
- The Social Insurance Institution of Finlad
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Those starting in one of the following services during April 2022 and January 2023:
- the Kela's integrated face-to-face rehabilitation and telerehabilitation service for family caregivers,
- the MTLH's face-to-face Social Holidays for family caregivers or
- the Kela's face-to-face rehabilitation services for family caregivers and care recipients
Description
Inclusion Criteria:
- family caregiver
- being 18 years of age or older
- providing daily care for an adult family member
participating in one of following:
- the Kela's integrated face-to-face rehabilitation and telerehabilitation service for family caregivers,
- the MTLH's face-to-face Social Holidays for family caregivers or
- the Kela's face-to-face rehabilitation services for family caregivers and care recipients
- willingness to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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)
|
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
|
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.
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|
Face-to-face rehabilitation
Participation in face-to-face rehabilitation services for family caregivers and the care recipients organized by Kela
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in mood at 5 months and 8 months
Time Frame: Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
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assessed with the Beck's Depression Inventory (BDI-21)
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Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Quality of life (QoL) at 5 months and 8 months
Time Frame: 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)
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Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
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Change from baseline in overall health at 5 months and 8 months
Time Frame: Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
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assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) survey
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Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
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|
Individual goal achievement
Time Frame: 5 months (after the intervention)
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assessed with the Goal Attainment Scaling method (GAS)
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5 months (after the intervention)
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Change from baseline in perceived burden of family care (I) at 5 months and 8 months
Time Frame: Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
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assessed with the Carers of Older People in Europe (COPE) index
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Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
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Change from baseline in perceived burden of family care (II) at 5 months and 8 months
Time Frame: Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
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assessed with the Adult Social Care Outcomes Toolkit (ASCOT) questionnaire
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Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Saija Karinkanta, PhD, The Social Insurance Institution of Finland (Kela)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2022
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
June 7, 2012
First Submitted That Met QC Criteria
December 22, 2022
First Posted (Actual)
January 10, 2023
Study Record Updates
Last Update Posted (Estimated)
December 4, 2024
Last Update Submitted That Met QC Criteria
November 29, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SocialII
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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