Clinical trial NCT02043262: The Effectiveness of Reablement in Home Dwelling Older Adults. A Randomized Controlled Trial
Official title: Evaluating Reablement for Home-dwelling Elderly in a Norwegian Municipality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Keywords: Elderly
Home-based rehabilitation
Activities of daily living
Restorative care
Reablement
Everyday rehabilitation
Lead sponsor: Bergen University College
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Diakonhjemmet Hospital
First posted: 2014-01-23
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: 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 older adults is effective with regards to functional ability and municipal costs.

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.

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: Canadian Occupational Performance Measure
timeFrame: Baseline
measure: Canadian Occupational Performance Measure
timeFrame: 3 months
measure: Canadian Occupational Performance Measure
timeFrame: 9 months
Secondary outcomes:
measure: Expenditure
timeFrame: Daily from baseline to 9 months.
measure: Expenditure
timeFrame: 15 months follow-up
Other outcomes:
measure: Timed Up and Go
timeFrame: Baseline
measure: COOP/Wonka
timeFrame: Baseline
measure: Dynamometer
timeFrame: Basline
measure: Timed Up and Go
timeFrame: 3 months
measure: Timed Up and Go
timeFrame: 9 months
measure: COOP/Wonka
timeFrame: 3 months
measure: COOP/Wonka
timeFrame: 9 months
measure: Dynamometer
timeFrame: 3 months
measure: Dynamometer
timeFrame: 9 months
Locations:
city: Bergen
country: Norway
facility: Bergen University College
city: Bergen
country: Norway
facility: Municpality of Voss
Study officials:
affiliation: Bergen University College
name: Frode Fa Jacobsen, PhD
role: STUDY_CHAIR
References:
citation: Tuntland H, Aaslund MK, Espehaug B, Forland O, Kjeken I. Reablement in community-dwelling older adults: a randomised controlled trial. BMC Geriatr. 2015 Nov 4;15:145. doi: 10.1186/s12877-015-0142-9.
citation: Tuntland H, Espehaug B, Forland O, Hole AD, Kjerstad E, Kjeken I. Reablement in community-dwelling adults: study protocol for a randomised controlled trial. BMC Geriatr. 2014 Dec 18;14:139. doi: 10.1186/1471-2318-14-139.