NCT05678946

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2012

Completed
9.8 years until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

June 7, 2012

Last Update Submit

November 29, 2024

Conditions

Keywords

rehabilitationeffectseffectivenesstelerehabilitationfamily caregiversinformal caregiversfamily caregivers burden

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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)

  • 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)

  • 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)

  • 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)

  • Individual goal achievement

    5 months (after the intervention)

Study Arms (3)

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

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

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

Interventions

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.

Integrated face-to-face rehabilitation and telerehabilitation

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.

Social Holidays

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.

Face-to-face rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those starting in one of the following services during April 2022 and January 2023: 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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Social Insurance Institution of Finlad

Helsinki, 00250, Finland

Location

Related 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.

    PMID: 33856279BACKGROUND

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Saija Karinkanta, PhD

    The Social Insurance Institution of Finland (Kela)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2012

First Posted

January 10, 2023

Study Start

April 11, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

December 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations