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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02043262
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : June 3, 2016
Sponsor:
Collaborators:
University of Bergen
Diakonhjemmet Hospital
Information provided by (Responsible Party):
Frode F. Jacobsen, Bergen University College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Physical Disability Behavioral: Reablement Behavioral: Standard treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Reablement for Home-dwelling Elderly in a Norwegian Municipality
Study Start Date : May 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2016

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.
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

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:
  • Usual care
  • Treatment as usual




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043262


Locations
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Norway
Bergen University College
Bergen, Norway, 5009
Municpality of Voss
Bergen, Norway, 5701
Sponsors and Collaborators
Frode F. Jacobsen
University of Bergen
Diakonhjemmet Hospital
Investigators
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Study Chair: Frode Fa Jacobsen, PhD Bergen University College
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Frode F. Jacobsen, Professor, Bergen University College
ClinicalTrials.gov Identifier: NCT02043262    
Other Study ID Numbers: 2012/295
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Frode F. Jacobsen, Bergen University College:
Elderly
Home-based rehabilitation
Activities of daily living
Restorative care
Reablement
Everyday rehabilitation