NCT03505619

Brief Summary

Reablement holds a potential to become a new rehabilitation model and has been implemented in some western countries including Norway and Denmark. At present, there is a lack of scientific evidence for the effectiveness of reablement and lack of an explicit theoretical underpinning, leading to a gap in knowledge. Trends show, however, that reablement is beneficial for the person and their significant others, increasing quality of life. There is a need for further investigation of the effects among community-dwelling adults in terms of clinical and economic outcomes. This research project will investigate the effectiveness of reablement including smart products (digitally based) (ASSIST) to facilitate and manage reablement services in home-dwelling adults compared with standard home help services in terms of daily activities, physical functioning, health-related quality of life, coping, mental health, use of health care services, and costs. Methods and analysis: This feasibility study will evaluate the perceived value and acceptability of ASSIST 1.0 intervention program as the fidelity, reach and dose, and potential outcomes by using a pre-post test design involving an intervention group and a control group (n=30). All participants will be living at home and with a need of home care services. Qualitative interviews among home care providers delivering ASSIST and older adults and their significant others receiving the intervention will be conducted to explore aspects affecting the intervention. Ethics and dissemination: The results will form the base for refinement of the "ASSIST" program and planning of a large-scale randomized, controlled trial investigating the effect of the program on quality of life as physical health, mental well-being, conditions for social community when focusing on supporting the older person's to meaningful everyday life. Dissemination will include peer-reviewed publications and presentations at national and international conferences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

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

First Submitted

Initial submission to the registry

January 22, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

January 22, 2018

Last Update Submit

September 21, 2020

Conditions

Keywords

home care servicereablement servicerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in Canadian Occupational Performance Measure (COPM)

    Measuring the older adults' self-perception of activity performance and satisfaction within the areas of self care, productivity and leisure, measured on a 1-10 scale, where 10 represents most satsified and highest performance ranking.

    Change between baseline and 8 to 10 weeks post baseline.

Secondary Outcomes (9)

  • Change in Barthel Index

    Change between baseline and 8 to 10 weeks post baseline.

  • Frenchay Activity Index (FAI)

    Change between baseline and 8 to 10 weeks post baseline.

  • The Swedish version of the General Self -Efficacy Scale)(GSE)

    Change between baseline and 8 to 10 weeks post baseline.

  • EQ5-D

    Change between baseline and 8 to 10 weeks post baseline.

  • Hospital Anxiety and Depression Scale (HAD)

    Change between baseline and 8 to 10 weeks post baseline.

  • +4 more secondary outcomes

Other Outcomes (4)

  • Creative Climate Questionnaire (CCQ)

    Change between baseline and 8 to 10 weeks post baseline.

  • QPS Nordic

    Change between baseline and 8 to 10 weeks post baseline.

  • Life Satisfaction Questionnaire (LiSat -11)

    Change between baseline and 8 to 10 weeks post baseline.

  • +1 more other outcomes

Study Arms (2)

ASSIST 1.0

EXPERIMENTAL

A ten-week intervention program using a person-centred approach to support the older person to set up goals to perform daily activities that he/she wants or needs to do. The activity goals will target improvements in quality of life, physical health, mental well-being, and conditions for social community. The focus will be on supporting the older person's activities in everyday life that are considered meaningful for the individual. During the intervention, a specially designed application will send reminders and feedback related to the older adults' activity goals of doing their prioritized everyday activities both to the older adults and to the home care providers via mobile phones, tablet etc. The home care providers will participate in coaching sessions supporting the intervention held by the team of researchers.

Behavioral: ASSIST 1.0

Ordinary home care services

NO INTERVENTION

The home care providers in the control group (CG) will provide services as usual to older adults participating in the control group. They will however, identify potential older persons to participate in the control group according to the same procedure and criteria as the intervention group.

Interventions

ASSIST 1.0BEHAVIORAL

10 weeks intervention applying a person-centred approach by using goal setting and smart products.

ASSIST 1.0

Eligibility Criteria

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

You may qualify if:

  • ≥65 years or older and live at home,
  • home care has been granted and the user is deemed not to need home rehabilitation performed by rehabilitation staff,
  • two or more identified challenges in everyday activities that can benefit from everyday rehabilitation,
  • are able to understand and express themselves in Swedish.

You may not qualify if:

  • have cognitive limitations that make reablement unappropriate,
  • in need of care in institutional dwelling or are terminally ill ,
  • the older adults have had home help services more than three years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholms Äldre förvaltning

Stockholm, Sweden

Location

Related Publications (2)

  • Assander S, Bergstrom A, Eriksson C, Meijer S, Guidetti S. ASSIST: a reablement program for older adults in Sweden - a feasibility study. BMC Geriatr. 2022 Jul 26;22(1):618. doi: 10.1186/s12877-022-03185-2.

  • Bergstrom A, Borell L, Meijer S, Guidetti S. Evaluation of an intervention addressing a reablement programme for older, community-dwelling persons in Sweden (ASSIST 1.0): a protocol for a feasibility study. BMJ Open. 2019 Jul 24;9(7):e025870. doi: 10.1136/bmjopen-2018-025870.

Study Officials

  • Lena Borell, professor

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The older adults will be included if they fulfil the following inclusion criteria a) ≥65 years or older and live at home, b) home care has been granted and the user is deemed not to need home rehabilitation performed by rehabilitation staff, c) two or more identified challenges in everyday activities that can benefit from everyday rehabilitation, d) are able to understand and express themselves in Swedish. One or more of the reasons will result in exclusion from the study: have cognitive limitations that make reablement unappropriate, in need of care in institutional dwelling or are terminally ill ,the older adults have had home help services more than three years. When the older person in either the intervention or control group agrees to be involved in the study, they will be asked if they could consider involving a significant other. The home care providers delivering ASSIST 1.0 or the ordinary home care will be included consisting of 8-10 staff from each group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A feasibility study with a pre-post-test design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD

Study Record Dates

First Submitted

January 22, 2018

First Posted

April 23, 2018

Study Start

November 1, 2018

Primary Completion

November 30, 2019

Study Completion

March 2, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations