NCT03565614

Brief Summary

Background: People live increasingly longer and are expected to function independently in their own homes to a greater extent than before. This puts great demands on the support given to older persons living at home, to be efficient and provide good conditions for them to manage on their own and experience good health. Short time goal directed reablement delivered by a multidisciplinary team is expected to strengthen the functional capacity and quality of life, while home care-hours and thus municipal expenditures decline. Theoretical focus of this project is related to international classification of functionality and disability (ICF) in which participation are understood as engagement in life situations and related to the environment as well as the person. Reablement is expected to extend the time of independent and autonomous life for older persons while also reducing municipal costs of elder care. Aim: This research project measures the effects of reablement in terms of bio-psycho-social health among older people (65+). In addition, the project highlights older person's experiences of the intervention and the professional team´s experiences of working with reablement. Methods: This is a randomized controlled study of the intervention reablement performed by the multiprofessional team with controls receiving usual home care. The effects are measured by self-reported health and quality of life, physical capacity, and home care hours. Data are collected at inclusion (applying for home care), after the three months intervention and at six months. Interviews with users are performed after the intervention, and staff experiences through written narratives. Impact of results: This project will contribute with collecting possible evidence of reablement, and contribute with knowledge development of older persons' bio-psycho-social health and experiences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

3.4 years

First QC Date

December 18, 2017

Last Update Submit

November 15, 2019

Conditions

Keywords

reablementolder peoplepersonal care servicesrehabilitationmultimorbiditydisability

Outcome Measures

Primary Outcomes (1)

  • Change in self-assessed overall life satisfaction

    Participants' overall life satisfaction ratings are included in the Health as Ability of Acting questionnaire (HACT; Snellman et al. 2011), which is based on Nordenfelt's theory of health (2004). These global ratings are made on a VAS scale, which is coded from 0 (very unsatisfied with life) to 100 (very satisfied with life).

    Change from baseline overall life satisfaction rating at 6 months

Secondary Outcomes (8)

  • Change in self-assessed general health

    Change from baseline self-assessed general health ratings at 6 months

  • Change in self-assessed health-related quality of life

    Change from baseline health-related quality of life ratings at 6 months

  • Change in self-assessed mental health

    Change from baseline mental health ratings at 6 months

  • Change in self-assessed health with respect to personal priorities

    Change from baseline self-assessed health with respect to personal priorities at 6 months

  • Change in self-assessed activity performance satisfaction

    Change from baseline activity performance satisfaction ratings at 6 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Number of home care hours needed at 6 months

    Home care hours needed at 6 months

Study Arms (2)

Reablement rehabilitation

EXPERIMENTAL

Reablement rehabilitation to maintain or increase the participants' physical, psychological and social functional abilities.

Behavioral: Reablement

Traditional home care

ACTIVE COMPARATOR

The traditional home care and required rehabilitation efforts as by the municipality's current practice.

Behavioral: Traditional home care

Interventions

ReablementBEHAVIORAL

Intensive home-based rehabilitation is delivered up to 3 months by an interprofessional team (nurse, enrolled nurse, physiotherapist, occupational therapist, social worker). The entire team completed a 5-week college course. The team negotiates goal-directed contents of the rehabilitation initiatives with the user. Each user is handled deliberately based on decisions in the team in cooperation with the care managers overarching goals in admitted services. All participants have personal contact persons, and these contact persons have twice the time per participant as compared to traditional home care. The interprofessional team also has regular meetings to discuss every participant, and all rehabilitation goals activities related to those are documented.

Reablement rehabilitation

Traditional home care and required rehabilitation efforts as by the municipality's current practice. Includes the same professions as is included in the reablement intervention, but the team has had no joint college course, does not use the systematic goal-directed and negotiated approach as the reablement intervention, and has about half the time per participant as compared to the reablement intervention.

Traditional home care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • older adults, over 65 years
  • residing in the central areas of Eskilstuna municipality
  • applying for social care and services delivered by the municipality of Eskilstuna

You may not qualify if:

  • life-threatening disease
  • severe mental illness
  • severe cognitive dysfunction
  • other conditions that prevent the participants from expressing their will or desires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskilstuna municipality, Care and social care service, Rehabilitation unit

Eskilstuna, Södermanland County, 63343, Sweden

Location

Related Publications (1)

  • Gustafsson LK, Soderman M, Johansson C, Elfstrom ML. Interprofessional homebased reablement intervention for older adults in Sweden: a randomized controlled trial. BMC Geriatr. 2025 Apr 10;25(1):242. doi: 10.1186/s12877-025-05886-w.

Study Officials

  • Lena-Karin Gustafsson, PhD

    Mälardalen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Older adults (65+) applying for social care and services delivered by a municipality (Eskilstuna) in the county of Södermanland, Sweden. Presumptive participants are identified by the municipality care mangers. After informed consent, the users are randomized to either the intervention or control group. Exclusion criteria: Life-threatening disease, diagnosed mental illness, or severe cognitive dysfunction that would prevent the participant from expressing wants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

June 21, 2018

Study Start

January 1, 2016

Primary Completion

June 5, 2019

Study Completion

August 31, 2019

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The unidentified research material will be available for 10 years after the research results have been publicized and then destroyed.
Access Criteria
If other researchers or authorities request access to the research material for review, Mälardalen University will examine the disclosure with accuracy. For example, the Privacy Act (2009: 40) will allow confidentiality of sensitive data is taken into account.

Locations