NCT02273934

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 18, 2015

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

September 29, 2014

Last Update Submit

November 17, 2015

Conditions

Physical Disability

Keywords

Home-based rehabilitationActivities of daily livingRestorative careReablementEveryday rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Expenditure

    Weekly from baseline to 6 months

  • Short Physical Performance Battery

    Baseline, 10 weeks, 6 months and 12 months

Other Outcomes (3)

  • Health-related Quality of Life

    Baseline, 10 weeks, 6 months and 12 months

  • Sense of coherence

    Baseline, 10 weeks, 6 months and 12 months

  • Mental Health Continuum

    Baseline, 10 weeks, 6 months and 12 months

Study Arms (2)

Reablement

EXPERIMENTAL

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 adults, and 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 person on a daily basis focusing on self-help.

Behavioral: Reablement

Standard treatment

ACTIVE COMPARATOR

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

Interventions

ReablementBEHAVIORAL

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
Reablement
Standard treatmentBEHAVIORAL

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

Also known as: Usual care, Treatment as usual
Standard treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive disability
  • Terminal ill
  • Being assessed as needing nursing home placement
  • Being assessed as needing institution-based rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bergen University College

Bergen, Bergen, 5020, Norway

Location

Related Publications (2)

  • 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.

    PMID: 30700255DERIVED

  • 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.

    PMID: 26374305DERIVED

Related Links

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Frode Jacobsen, PhD

    Bergen University College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 24, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 18, 2015

Record last verified: 2015-06

Locations

NO(1)