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Completed

NCT Number: NCT02043262

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bergen University College, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reablement

Behavioral

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

Standard treatment

Behavioral

The control intervention is standard home-based treatment/care in Norway.

Other names: Usual care, Treatment as usual

Primary outcomes

  1. 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.

  2. 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. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Dynamometer

    Time frame: Basline

    Hand strength will be measured with a hydraulic hand dynamometer. Normative grip strength data exists.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Dynamometer

    Time frame: 3 months

    Hand strength will be measured with a hydraulic hand dynamometer.

  9. Dynamometer

    Time frame: 9 months

    Hand strength will be measured with a hydraulic hand dynamometer.

Sponsors and collaborators

Lead sponsor

Frode F. Jacobsen

Other

Collaborators

  • Diakonhjemmet Hospital
  • University of Bergen

Registry information

Official study title

Evaluating Reablement for Home-dwelling Elderly in a Norwegian Municipality

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jan 23, 2014
Registry last updated
Jun 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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