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Older AdultsNCT03505619

ASSIST 1.0 an Intervention Program Addressing Reablement Services

A study testing ASSIST 1.0 in people with Older Adults and Participation, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Older Adults, Participation
What is being tested?
ASSIST 1.0
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSweden
Study dates
1 Nov 2018to 2 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • ≥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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Stockholms Äldre förvaltning

    Stockholm

Other trials in Sweden

About this study

Official title: Evaluation of an Intervention Program Addressing Reablement Services in a Swedish Context (ASSIST 1.0) - A Protocol for a Feasibility Study

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.

Being tested
ASSIST 1.0
Keywords
home care service, reablement service, rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASSIST 1.0Behavioural

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

Study groups in NCT03505619
Study groupRoleWhat they receive
ASSIST 1.0ExperimentalA 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.
Receives: Behavioral: ASSIST 1.0
Ordinary home care servicesNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change between baseline and 8 to 10 weeks post baseline.

Secondary outcomes (9)

  1. Change in Barthel Index

    The Barthel Index (BI) will be administered at inclusion and post baseline will used in the present study to determine stroke severity, where scores of < 15 represented a severe stroke, 15-49 a moderate stroke, and 50-100 a mild stroke.

    Measured: Change between baseline and 8 to 10 weeks post baseline.

  2. Frenchay Activity Index (FAI)

    The FAI consist of 15 items, the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months, and ranges from 0 (inactive) to 45 (very active).

    Measured: Change between baseline and 8 to 10 weeks post baseline.

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

    Measure the perceived belief in one's ability in different situations. The GSE scale consists of ten statements such as "I can solve most problems if I invest the necessary effort." Possible responses are scored 1-4, where 1 represents "Not at all true", 2 "Hardly true", 3 "Moderately true" and 4 "Exactly true". This gives a total score ranging from 10-40; higher scores indicate a greater sense of general self-efficacy. The GSE has been translated into Swedish and has been demonstrated to be valid.

    Measured: Change between baseline and 8 to 10 weeks post baseline.

  4. EQ5-D

    EQ5-D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale.

    Measured: Change between baseline and 8 to 10 weeks post baseline.

  5. Hospital Anxiety and Depression Scale (HAD)

    The HADS is a screening instrument, which comprises Anxiety and Depression subscales, each with seven items and total scores ranging from 0-21. Higher scores indicate lower mood, i.e., more anxiety or depressive symptoms respectively. The recommended cut-offs for both subscales in people with stroke is ≥4

    Measured: Change between baseline and 8 to 10 weeks post baseline.

  6. Mental Health Continuum -short form, Swedish version (MHC-SF)

    Measure emotional well-being, social well-being and psychological well-being.

    Measured: Change between baseline and 8 to 10 weeks post baseline.

  7. Reintegration of Normal Living Index- (RNL)

    The RNLI index is made up of 11 declarative statements (e.g. I move around my living quarters as I feel necessary), including the following domains: indoor, community, and distance mobility; self-care; daily activity (work and school); recreational and social activities;; family role(s); personal relationships; presentation of self to others and general coping skills. The first 8 items represent 'daily functioning' and the remaining 3 items represent 'perception of self'.Each domain is accompanied by a visual analogue scale (VAS) (0 to 10 cm). The VAS is anchored by the statements "does not describe my situation" (1 or minimal integration) and "fully describes my situation" (10 or complete integration). Individual item scores are summed to provide a total score out of 110 points that is proportionally converted to create a score out of 100.

    Measured: Change between baseline and 8 to 10 weeks post baseline.

  8. Change in Sense of Coherence

    Short form measure on one's sense of health.

    Measured: Change between baseline and 8 to 10 weeks post baseline.

  9. Change in Katz ADL extended scale

    The Katz Extended Scale (KE) will be used to assess self-reported need of assistance (yes/no) in six personal ADL (PADL) and four instrumental ADL (IADL) both pre- and post-stroke.

    Measured: Change between baseline and 8 to 10 weeks post baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2018
  2. Study start1 Nov 2018
  3. Primary completion30 Nov 2019
  4. Study completion2 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A feasibility study with a pre-post-test design.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03505619
Sponsor's protocol ID
ASSIST 1.0
Status last verified
Sep 2020
First submitted
22 Jan 2018
Last updated
22 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35879678

  • 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.

    PubMed 31345964

Questions about this trial

What is this clinical trial studying?

A study testing ASSIST 1.0 in people with Older Adults and Participation, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Canadian Occupational Performance Measure (COPM) (time frame: Change between baseline and 8 to 10 weeks post baseline.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03505619, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.

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