Clinical trial NCT02273934: The Effectiveness of Reablement in Home Dwelling Adults
Official title: The Effectiveness of Reablement in Home Dwelling Adults. A Quasi Experimental Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Disability
Keywords: Home-based rehabilitation
Activities of daily living
Restorative care
Reablement
Everyday rehabilitation
Lead sponsor: Bergen University College
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: University of Bergen
First posted: 2014-10-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in score in Canadian Occupational Performance Measure
timeFrame: Baseline, 10 weeks, 6 months and 12 months
Secondary outcomes:
measure: Expenditure
timeFrame: Weekly from baseline to 6 months
measure: Short Physical Performance Battery
timeFrame: Baseline, 10 weeks, 6 months and 12 months
Other outcomes:
measure: Health-related Quality of Life
timeFrame: Baseline, 10 weeks, 6 months and 12 months
measure: Sense of coherence
timeFrame: Baseline, 10 weeks, 6 months and 12 months
measure: Mental Health Continuum
timeFrame: Baseline, 10 weeks, 6 months and 12 months
Locations:
city: Bergen
country: Norway
facility: Bergen University College
Study officials:
affiliation: Bergen University College
name: Frode Jacobsen, PhD
role: STUDY_CHAIR
References:
citation: Langeland E, Tuntland H, Folkestad B, Forland O, Jacobsen FF, Kjeken I. A multicenter investigation of reablement in Norway: a clinical controlled trial. BMC Geriatr. 2019 Jan 30;19(1):29. doi: 10.1186/s12877-019-1038-x.
citation: Langeland E, Tuntland H, Forland O, Aas E, Folkestad B, Jacobsen FF, Kjeken I. Study protocol for a multicenter investigation of reablement in Norway. BMC Geriatr. 2015 Sep 15;15:111. doi: 10.1186/s12877-015-0108-y.