The Effectiveness of Reablement in Home Dwelling Adults

Physical Disability Clinical Trial

Official title:

The Effectiveness of Reablement in Home Dwelling Adults. A Quasi Experimental Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02273934
• Other study ID #: EL-123-REHAB
• Status: Active, not recruiting
• Phase: N/A
• First received: September 29, 2014
• Last updated: November 17, 2015
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• 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 adults is effective with regards to functional ability, health-related quality of life, coping, mental health and municipal costs.

Description:

Health promotion and prevention of functional decline among home dwelling adults and immediate onset of rehabilitation, can improve function, and reduce or delay need for home-based assistance and institution placement. In the coming years there will be a significant increase in number of persons in Norway that need interventions aiming at coping with everyday activities. Therefore there is a call for new models for early intervention and rehabilitation in order to give service to a larger amount of home living people. 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 performed regarding the effectiveness of this intervention. This study aims at assessing the effectiveness of reablement in terms of daily functioning, health-related quality of life, coping, mental health and economic municipal costs.

The study will be conducted in 44 municipalities in Norway. It is a quasi-experimental intervention trial, recruiting home-dwelling 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, nurse or a physiotherapist. The control intervention is standard home-based treatment and care.

A total of approximately 750 participants will be recruited, including approximately 100 participants the control group. The participants will be assessed at baseline, and at 10 weeks ,6-, and 12 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 weekly registration of the working hours different health care professions spend in the private homes of the participants.

Data analyses will be performed according to intention to treat. Univariate analysis of covariance will be used to investigate differences between the groups from baseline to the end of intervention. 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: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: December 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: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, 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

Sponsors (3)

Lead Sponsor	Collaborator
Frode F. Jacobsen	University of Bergen, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related Quality of Life	Health-related Quality of Life (EQ-5D) measures health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses.	Baseline, 10 weeks, 6 months and 12 months	No
Other	Sense of coherence	Sense of coherence (SOC) measures comprehensibility (5 items), manageability (4 items) and meaning (4 items).	Baseline, 10 weeks, 6 months and 12 months	No
Other	Mental Health Continuum	Mental Health Continuum Short Form (MHC-SF) measures emotional (3 items), psychological (6 items) and social (5 items) well-being.	Baseline, 10 weeks, 6 months and 12 months	No
Primary	Change in score in 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, 10 weeks, 6 months and 12 months	No
Secondary	Expenditure	Municipal expenditures will be recorded weekly for six months. Costs will be recorded in accordance with the operating hours of the different health care professions in the private homes of the participants.	Weekly from baseline to 6 months	No
Secondary	Short Physical Performance Battery	Short Physical Performance Battery (SPPB) investigates balance, walking function and muscle strength in the lower limbs.	Baseline, 10 weeks, 6 months and 12 months	No

External Links

•   Published study protocol