An interventional study of Reablement and Standard treatment in Physical Disability, sponsored by Frode F. Jacobsen. Completed at 2 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-03.
Sponsored by Frode F. Jacobsen · Not applicable, Interventional, and Treatment
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.
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.
Frode F. Jacobsen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 intervention deals with improving function in daily activities the person defines as important in the areas of self-care, productivity and leisure.
Also known as: Hverdagsrehabilitering, Hemrehabilitering, Re-ablement, Restorative care
The control intervention is standard home-based treatment/care in Norway.
Also known as: Usual care, Treatment as usual
Canadian Occupational Performance Measure
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.
Time frame: Baseline
Canadian Occupational Performance Measure
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.
Time frame: 3 months
Canadian Occupational Performance Measure
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.
Time frame: 9 months
Expenditure
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.
Time frame: Daily from baseline to 9 months.
Expenditure
The control group will be assessed for amount of municipal home-based help at 15 months follow-up.
Time frame: 15 months follow-up
Timed Up and Go
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.
Time frame: Baseline
COOP/Wonka
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.
Time frame: Baseline
Dynamometer
Hand strength will be measured with a hydraulic hand dynamometer. Normative grip strength data exists.
Time frame: Basline
Timed Up and Go
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.
Time frame: 3 months
Timed Up and Go
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.
Time frame: 9 months
COOP/Wonka
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.
Time frame: 3 months
COOP/Wonka
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.
Time frame: 9 months
Dynamometer
Hand strength will be measured with a hydraulic hand dynamometer.
Time frame: 3 months
Dynamometer
Hand strength will be measured with a hydraulic hand dynamometer.
Time frame: 9 months
Plan to share: No
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Frode F. Jacobsen