NCT02043262

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

May 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

3.1 years

First QC Date

November 20, 2012

Last Update Submit

June 2, 2016

Conditions

Physical Disability

Keywords

ElderlyHome-based rehabilitationActivities of daily livingRestorative careReablementEveryday rehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (2)

  • Expenditure

    Daily from baseline to 9 months.

  • Expenditure

    15 months follow-up

Other Outcomes (9)

  • Timed Up and Go

    Baseline

  • COOP/Wonka

    Baseline

  • Dynamometer

    Basline

  • +6 more other outcomes

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 older adults, although 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 older 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 (2)

Bergen University College

Bergen, 5009, Norway

Location

Municpality of Voss

Bergen, 5701, Norway

Location

Related Publications (2)

  • 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.

    PMID: 26537789DERIVED

  • 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.

    PMID: 25519828DERIVED

Related Links

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Frode Fa Jacobsen, PhD

    Bergen University College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2012

First Posted

January 23, 2014

Study Start

May 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)