The Effectiveness of Reablement in Home Dwelling Older Adults. A Randomized Controlled Trial

June 2, 2016 updated by: Frode F. Jacobsen

Evaluating Reablement for Home-dwelling Elderly in a Norwegian Municipality

The purpose of this study is to determine whether a special kind of rehabilitation offered to home-dwelling older adults is effective with regards to functional ability and municipal costs.

Study Overview

Status

Completed

Conditions

Detailed Description

Early detection of functional decline among home dwelling older adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and nursing home placement. Towards year 2050 there will be a significant increase in number of elderly persons in Norway, with an urgent need for new models for early intervention and rehabilitation in order to give service to a larger amount of elderly persons. 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 conducted regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning and economic costs compared to standard home-based treatment and care.

The study will be conducted in the municipality of Voss in Western Norway, a municipality with only 14000 inhabitants. It is a double-blinded, block-randomized controlled intervention trial, recruiting home-dwelling older 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 or a physiotherapist. The control intervention is standard home-based treatment and care.

Thirty participants will be recruited in each arm of the study. The participants will be assessed at baseline, and at 3-, and 9 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 daily registration of the working hours different health care professions spend in the private homes of the participants.

Power calculations based on study with a similar target group using the instrument Canadian Occupational Performance Measure, estimate a need for only 21 participants in each group due to the longitudinal design. However, in order to account for possibilities of frailer target group or a large drop out rate (40 %), a total number of 30 participants in each group will be tried recruited. Data analyses will be performed according to intention to treat. 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 (Actual)

61

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

      • Bergen, Norway, 5009
        • Bergen University College
      • Bergen, Norway, 5701
        • Municpality of Voss

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 older adults, although 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 older person on a daily basis focusing on self-help.
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
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.
The control intervention is standard home-based treatment/care in Norway.
Other Names:
  • Treatment as usual
  • Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure
Time Frame: Baseline
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
Canadian Occupational Performance Measure
Time Frame: 3 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.
3 months
Canadian Occupational Performance Measure
Time Frame: 9 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.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expenditure
Time Frame: Daily from baseline to 9 months.
Municipal expenditures will be recorded daily for nine months. Costs will be recorded in accordance with the operating hours of the different health care professions in the private homes of the participants. The control group will be assessed for amount of municipal home-based help at 15 months follow-up.
Daily from baseline to 9 months.
Expenditure
Time Frame: 15 months follow-up
The control group will be assessed for amount of municipal home-based help at 15 months follow-up.
15 months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go
Time Frame: Baseline
Mobility will be measured using "The Timed Up and Go" (TUG). This is a simple, clinical performance-based measure of lower extremity function, mobility and fall risk. Normative data exists.
Baseline
COOP/Wonka
Time Frame: Baseline
COOP/Wonka is a generic patient oriented instrument covering the domains of physical fitness, feelings, daily activities, social activities, change in health and overall health.
Baseline
Dynamometer
Time Frame: Basline
Hand strength will be measured with a hydraulic hand dynamometer. Normative grip strength data exists.
Basline
Timed Up and Go
Time Frame: 3 months
Mobility will be measured using "The Timed Up and Go" (TUG). This is a simple, clinical performance-based measure of lower extremity function, mobility and fall risk.
3 months
Timed Up and Go
Time Frame: 9 months
Mobility will be measured using "The Timed Up and Go" (TUG). This is a simple, clinical performance-based measure of lower extremity function, mobility and fall risk.
9 months
COOP/Wonka
Time Frame: 3 months
COOP/Wonka is a generic patient oriented instrument covering the domains of physical fitness, feelings, daily activities, social activities, change in health and overall health.
3 months
COOP/Wonka
Time Frame: 9 months
COOP/Wonka is a generic patient oriented instrument covering the domains of physical fitness, feelings, daily activities, social activities, change in health and overall health.
9 months
Dynamometer
Time Frame: 3 months
Hand strength will be measured with a hydraulic hand dynamometer.
3 months
Dynamometer
Time Frame: 9 months
Hand strength will be measured with a hydraulic hand dynamometer.
9 months

Collaborators and Investigators

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

Investigators

  • Study Chair: Frode Fa 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.

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

May 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

January 21, 2014

First Posted (ESTIMATE)

January 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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