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

Physical Disability Clinical Trial

Official title:

Evaluating Reablement for Home-dwelling Elderly in a Norwegian Municipality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043262
• Other study ID #: 2012/295
• Status: Completed
• Phase: N/A
• First received: November 20, 2012
• Last updated: June 2, 2016
• Start date: May 2012
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Bergen University College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physical Disability

Intervention

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

Locations

Country	Name	City	State
Norway	Bergen University College	Bergen
Norway	Municpality of Voss	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
Frode F. Jacobsen	Diakonhjemmet Hospital, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline	No
Other	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.	Baseline	No
Other	Dynamometer	Hand strength will be measured with a hydraulic hand dynamometer. Normative grip strength data exists.	Basline	No
Other	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.	3 months	No
Other	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.	9 months	No
Other	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.	3 months	No
Other	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.	9 months	No
Other	Dynamometer	Hand strength will be measured with a hydraulic hand dynamometer.	3 months	No
Other	Dynamometer	Hand strength will be measured with a hydraulic hand dynamometer.	9 months	No
Primary	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.	Baseline	No
Primary	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.	3 months	No
Primary	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.	9 months	No
Secondary	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.	Daily from baseline to 9 months.	No
Secondary	Expenditure	The control group will be assessed for amount of municipal home-based help at 15 months follow-up.	15 months follow-up	No

External Links

•   Published cost-effectiveness study
•   Published randomised controlled trial