NCT04588116

Brief Summary

The purpose of the study is to evaluate the feasibility and potential outcomes of a first version of a web-based intervention in occupational therapy focusing on empowering an active everyday life for people with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable stroke

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

October 2, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

2.7 years

First QC Date

October 2, 2020

Last Update Submit

August 29, 2024

Conditions

Keywords

Stroke, self-management,activities of daily life,life-style intervention,web-based rehabilitation,tele-rehabilitation,digital e- health solutions,occupational therapy

Outcome Measures

Primary Outcomes (3)

  • The profiles of occupational engagement (POES)

    Change in activity pattern/profile.The POES is based on an interview of an 24 h completed diary of time use. The nine items are scored on an ordinal scale ranging from 1 to 4. A higher score indicates a higher level of engagement in activities.

    Change from baseline to four- and twelve-months post-base line.

  • Occupational Balance Questionnaire (OBQ)

    Change in occupational balance, reflecting a person's subjective perception of having the right amount of activities and the right variation between activities. The OBQ consist of 11 items that are rated on a four-point ordinal scale, scored 0 to 3. The ratings of the OBQ are summed to a total score, ranging between 0 and 33. A higher score implies more satisfaction with the amount and variation of occupations, i.e., a higher level of occupational balance.

    Change from baseline to four- and twelve-months post-base line

  • Occupational values with pre-defined items (Oval-pd).

    Change in occupational values, reflecting a person's subjective perception of concrete, symbolic or self-rewarding values in activities. The OVal-pd consists of 18 items rated on a four-point ordinal scale with response options scored 1 to 4. The rating of the OVal-pd can be summed into a general occupational value, ranging between 18-72. .A higher score indicates that the respondent is frequently engaged in valued occupation.

    Change from baseline to four- and twelve-months post-base line

Secondary Outcomes (4)

  • Life satisfaction questionnaire (Lisat-11)

    Change from baseline to four- and twelve-months post-base line

  • The general self- efficacy scale (S-GSE)

    Change from baseline to four- and twelve-months post-base line

  • Work ability index (WAI)

    Change from baseline to four- and twelve-months post-base line

  • Stroke Impact Scale, participation (SIS)

    Change from baseline to four- and twelve-months post-base line

Other Outcomes (4)

  • The clients' (own) experiences of adopting activity-based strategies during the intervention process of SEE and the influence of these for an active life

    Repeatedly interviews during the intervention process, one- and fourth months post- baseline

  • The acceptability and value of the the SEE from the perspective of the receivers

    Four- and twelve months post- baseline

  • The adherence of the SEE

    During each patient's intervention process, every planned intervention occasion (according to the intervention guide), up to twelve months post-base line.

  • +1 more other outcomes

Study Arms (1)

The web- based occupational therapy intervention SEE

EXPERIMENTAL

The web-based intervention starts with eight educational modules focusing on engagement in activities and strategies to support an active life. The modules, that is delivered on a secure national health platform, include short education videos followed by self-reflections and digital assignments supporting the change process. The occupational therapist provides feedback after each assignment and, also, meet the patients for face- to- face online guiding sessions at three times during these first two- three weeks of the intervention. Thereafter, an individually tailored activity plan with goals and activity-based strategies are established. During the change process, the patients receive continued support from the occupational therapist until the goals are achieved.

Behavioral: Strategies Empowering activities in Everyday life (SEE 1.0)

Interventions

The patients are provided a person-centered activity-based intervention on the web aiming at facilitating the level of engagement in a variety of activities, at different places in society, together with other people to support an active life. In the long-term, the change to an active life will be reflected in a healthy and balanced pattern of activities. The program provide the patients with tools to "see" their activities in everyday life in a new light and, also, tools to identify activity-based strategies that can empower them to take an active role to prevent and overcome challenging situations in everyday life.

Also known as: Strategies Empowering activities in Everyday life (SEE 1.0) A web-based occupational therapy intervention for people with stroke
The web- based occupational therapy intervention SEE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke
  • Age: 18-75 years
  • three to thirty six months after the onset of the stroke
  • have moderate disability or good recovery after the stroke
  • have access to a screen/computer, internet and e-ID as well as being able to use them
  • experience limitations in activities in everyday life
  • be motivated to participate in the program, including be ready for a process of change
  • be discharged from rehabilitation at hospital or day care.

You may not qualify if:

  • depression
  • other conditions or diseases that impact on activities in everyday life
  • have impairments or other diagnoses to such an extent that may have an impact on the ability to consent participation as well as participate in the data collection and intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health Science, LTU

Luleå, 97187, Sweden

Location

Related Publications (2)

  • Larsson-Lund M, Barcheus IM, Ranner M, Vikman I, Jacobsson L, Lexell EM. A feasibility study of the internet-based intervention "Strategies for Empowering activities in Everyday life" (SEE 1.0) applied for people with stroke. BMC Health Serv Res. 2025 Mar 4;25(1):330. doi: 10.1186/s12913-025-12456-8.

  • Larsson-Lund M, Mansson Lexell E, Nyman A. Strategies for Empowering activities in Everyday life (SEE 1.0): study protocol for a feasibility study of an Internet-based occupational therapy intervention for people with stroke. Pilot Feasibility Stud. 2021 Oct 16;7(1):187. doi: 10.1186/s40814-021-00924-x.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Maria A Larsson-Lund, Prof

    Luleå University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A feasibility study with a pre-test post-test design without control group embedded in a mix-method approach.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chaired Professor

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 19, 2020

Study Start

November 1, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Due to Swedish law, acts and regulations it is not possible to share data open. Data are archived at Luleå university of technology. Request for access the data can be sent to registrator@ltu.se

Locations