The Effectiveness of Reablement in Home Dwelling Adults

November 17, 2015 updated by: Frode F. Jacobsen

The Effectiveness of Reablement in Home Dwelling Adults. A Quasi Experimental Trial

The purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling adults is effective with regards to functional ability, health-related quality of life, coping, mental health and municipal costs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Health promotion and prevention of functional decline among home dwelling adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and institution placement. In the coming years there will be a significant increase in number of persons in Norway that need interventions aiming at coping with everyday activities. Therefore there is a call for new models for early intervention and rehabilitation in order to give service to a larger amount of home living people. Reablement is a new and promising rehabilitation model which many Norwegian municipalities are implementing in order to meet current and future needs for municipal home-based services. However, very little research has been performed regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning, health-related quality of life, coping, mental health and economic municipal costs.

The study will be conducted in 44 municipalities in Norway. It is a quasi-experimental intervention trial, recruiting home-dwelling adults with an initial functional decline in daily activities. The intervention is intensive, multidisciplinary, home-based rehabilitation given by home-trainers, under supervision from an occupational therapist, nurse or a physiotherapist. The control intervention is standard home-based treatment and care.

A total of approximately 750 participants will be recruited, including approximately 100 participants the control group. The participants will be assessed at baseline, and at 10 weeks ,6-, and 12 months follow-up. Primary outcomes will be participation, activity, and municipal expenditures. Costs are generated by the working hours of the different professions. Hence, there will be a weekly registration of the working hours different health care professions spend in the private homes of the participants.

Data analyses will be performed according to intention to treat. Univariate analysis of covariance will be used to investigate differences between the groups from baseline to the end of intervention. The working hour data is panel data and will be analyzed accordingly; a random or a mixed effect regression model will be employed. Also, descriptive statistics and simpler tests will be carried out.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

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

  • Norway
      • Bergen, Norway, 5020
        • Bergen University College

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Home-dwelling person
  • Applicant of home-based services
  • Above 18 years old
  • Functional decline in at least one activity
  • Able to understand written and oral Norwegian

Exclusion Criteria:

  • Cognitive disability
  • Terminal ill
  • Being assessed as needing nursing home placement
  • Being assessed as needing institution-based rehabilitation

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

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard treatment
This arm consists of the standard treatment home-dwelling elderly persons receive when applying for home-based help. Some elderly may receive home-based nursing or home help services assisting them in daily activities, while others may receive occupational therapy or physical therapy measures for rehabilitative purposes.
Behavioral: Standard treatment
The control intervention is standard home-based treatment/care in Norway.
Other Names:
  • Treatment as usual
  • Usual care
EXPERIMENTAL: Reablement
Reablement is an intensive, multidisciplinary, client-centered, home-based type of rehabilitation, where ordinary activities of daily living are used for rehabilitative purposes. It is a rehabilitation alternative that may be offered to adults, and there is no lower age limit. An occupational therapist and physical therapist, or nurse, constitutes the key personal, while home helpers, assistants and others with lower education, are the ones who work rehabilitative with the person on a daily basis focusing on self-help.
Behavioral: Reablement
The intervention deals with improving function in daily activities the person defines as important in the areas of self-care, productivity and leisure.
Other Names:
  • Hverdagsrehabilitering
  • Hemrehabilitering
  • Re-ablement
  • Restorative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in score in Canadian Occupational Performance Measure
Time Frame: Baseline, 10 weeks, 6 months and 12 months
Activity and participation will be measured using Canadian Occupational Performance Measure (COPM) The COPM is a measure of a client's self-perception of occupational performance in the areas of self-care, productivity and leisure. Outcome measures for the COPM are: the client's most important problems in occupational performance and a total score of performance and a total score of satisfaction for these problems.
Baseline, 10 weeks, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expenditure
Time Frame: Weekly from baseline to 6 months
Municipal expenditures will be recorded weekly for six months. Costs will be recorded in accordance with the operating hours of the different health care professions in the private homes of the participants.
Weekly from baseline to 6 months
Short Physical Performance Battery
Time Frame: Baseline, 10 weeks, 6 months and 12 months
Short Physical Performance Battery (SPPB) investigates balance, walking function and muscle strength in the lower limbs.
Baseline, 10 weeks, 6 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life
Time Frame: Baseline, 10 weeks, 6 months and 12 months
Health-related Quality of Life (EQ-5D) measures health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses.
Baseline, 10 weeks, 6 months and 12 months
Sense of coherence
Time Frame: Baseline, 10 weeks, 6 months and 12 months
Sense of coherence (SOC) measures comprehensibility (5 items), manageability (4 items) and meaning (4 items).
Baseline, 10 weeks, 6 months and 12 months
Mental Health Continuum
Time Frame: Baseline, 10 weeks, 6 months and 12 months
Mental Health Continuum Short Form (MHC-SF) measures emotional (3 items), psychological (6 items) and social (5 items) well-being.
Baseline, 10 weeks, 6 months and 12 months

Collaborators and Investigators

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

Sponsor

Frode F. Jacobsen

Collaborators

University of Oslo
University of Bergen

Investigators

  • Study Chair: Frode Jacobsen, PhD, Bergen University College

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

April 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (ESTIMATE)

October 24, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EL-123-REHAB

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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