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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Finland
      • Helsinki, Finland, 00250
        • The Social Insurance Institution of Finlad

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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

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:

    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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
assessed with the Beck's Depression Inventory (BDI-21)
Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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
Time Frame: 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
Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)
Individual goal achievement
Time Frame: 5 months (after the intervention)
assessed with the Goal Attainment Scaling method (GAS)
5 months (after the intervention)
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)
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)
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)
assessed with the Adult Social Care Outcomes Toolkit (ASCOT) questionnaire
Baseline (pre-intervention), 5 months (after the intervention), 8 months (3-month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Social Insurance Institution, Finland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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