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Strategies Empowering Activities in Everyday Life (SEE 1.0) A Web-based Occupational Therapy Intervention

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Strategies Empowering activities in Everyday life (SEE 1.0)
Sponsored by
Luleå Tekniska Universitet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, self-management,, activities of daily life,, life-style intervention,, web-based rehabilitation,, tele-rehabilitation,, digital e- health solutions,, occupational therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Department of Health Science, LTU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The web- based occupational therapy intervention SEE

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Life satisfaction questionnaire (Lisat-11)
Change in life satisfaction. The Life satisfaction questionnaire consist of 11 items rated on a six-point ordinal scale ranging from 1 to 6. A higher score reflects a higher level of satisfaction.
The general self- efficacy scale (S-GSE)
Change in general self- efficacy. The S-GSE consist of 10 items that are rated on a four-point ordinal scale, ranging from 1 to 4. The summarized score range between 10-40. A higher score reflects greater sense of general self-efficacy.
Work ability index (WAI)
Change in self-perceived work ability. In the WAI, self-perceived work ability is rated on a ten -point ordinal scale. A higher score reflects a higher level of perceived work ability.
Stroke Impact Scale, participation (SIS)
Change in impact of stroke on participation is rated on a five-point ordinal scale. A higher score reflects a higher level of participation

Full Information

First Posted
October 2, 2020
Last Updated
September 8, 2023
Sponsor
Luleå Tekniska Universitet
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1. Study Identification

Unique Protocol Identification Number
NCT04588116
Brief Title
Strategies Empowering Activities in Everyday Life (SEE 1.0) A Web-based Occupational Therapy Intervention
Official Title
Strategies Empowering Activities in Everyday Life (SEE 1.0): A Study Protocol for a Feasibility Trial of a Web-based Occupational Therapy Intervention for People With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luleå Tekniska Universitet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A large amount of people with stroke face extensive changes to live an active life and restrictions in engaging in various activities are common. However, the rehabilitation seldom focusses on the process of change people with stroke need to go through to adapt to their changed capacity and reach an active life on new terms. This implies that rehabilitation needs to be developed to provide activity-based self-management strategies that can facilitate an active life. Also, there is a need to improve the access to rehabilitation by making use of digital e- health solutions. Based on these needs, the web-based occupational therapy intervention "Strategies Empowering activities in Everyday life" (SEE 1.0) has been developed. This feasibility trial has a pre-test post-test design without a control group. The trial is embedded in a mix- method approach combining assessment tools, feasibility registration forms, intervention logbooks, qualitative interviews and focus groups. The feasibility of the web-based intervention SEE as well as of the study design, will be evaluated in terms of acceptability, adherence, values and appropriateness from the perspectives of patients with stroke and the staff. Also, the potential outcome of SEE will be evaluated quantitatively and qualitatively. The results will support the continued development of SEE and provide for larger-scale research studies. The intervention, that combines a focus on empowering an active everyday life with a web-based format including online meetings, is innovative and is not part of clinical practice today. Thereby, the results can be valuable for future research and clinical practice in general. The study protocol and the results will be published in peer-reviewed scientific journals and presented at conferences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, self-management,, activities of daily life,, life-style intervention,, web-based rehabilitation,, tele-rehabilitation,, digital e- health solutions,, occupational therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A feasibility study with a pre-test post-test design without control group embedded in a mix-method approach.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The web- based occupational therapy intervention SEE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strategies Empowering activities in Everyday life (SEE 1.0)
Other Intervention Name(s)
Strategies Empowering activities in Everyday life (SEE 1.0) A web-based occupational therapy intervention for people with stroke
Intervention Description
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.
Primary Outcome Measure Information:
Title
The profiles of occupational engagement (POES)
Description
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.
Time Frame
Change from baseline to four- and twelve-months post-base line.
Title
Occupational Balance Questionnaire (OBQ)
Description
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.
Time Frame
Change from baseline to four- and twelve-months post-base line
Title
Occupational values with pre-defined items (Oval-pd).
Description
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.
Time Frame
Change from baseline to four- and twelve-months post-base line
Secondary Outcome Measure Information:
Title
Life satisfaction questionnaire (Lisat-11)
Description
Change in life satisfaction. The Life satisfaction questionnaire consist of 11 items rated on a six-point ordinal scale ranging from 1 to 6. A higher score reflects a higher level of satisfaction.
Time Frame
Change from baseline to four- and twelve-months post-base line
Title
The general self- efficacy scale (S-GSE)
Description
Change in general self- efficacy. The S-GSE consist of 10 items that are rated on a four-point ordinal scale, ranging from 1 to 4. The summarized score range between 10-40. A higher score reflects greater sense of general self-efficacy.
Time Frame
Change from baseline to four- and twelve-months post-base line
Title
Work ability index (WAI)
Description
Change in self-perceived work ability. In the WAI, self-perceived work ability is rated on a ten -point ordinal scale. A higher score reflects a higher level of perceived work ability.
Time Frame
Change from baseline to four- and twelve-months post-base line
Title
Stroke Impact Scale, participation (SIS)
Description
Change in impact of stroke on participation is rated on a five-point ordinal scale. A higher score reflects a higher level of participation
Time Frame
Change from baseline to four- and twelve-months post-base line
Other Pre-specified Outcome Measures:
Title
The clients' (own) experiences of adopting activity-based strategies during the intervention process of SEE and the influence of these for an active life
Description
Experiences of adopting activity-based strategies during the intervention process of the SEE and the influence of these for an active life will be explored by qualitative interviews
Time Frame
Repeatedly interviews during the intervention process, one- and fourth months post- baseline
Title
The acceptability and value of the the SEE from the perspective of the receivers
Description
The acceptability and value of the SEE from the perspective of the receivers will be studied with a study specific questionnaire. The items are rated on four-graded ordinal scale, ranging from 1 to 4. Higher scores reflect higher levels of acceptability and values of the SEE.
Time Frame
Four- and twelve months post- baseline
Title
The adherence of the SEE
Description
The adherence of the SEE will be studied with a study specific feasibility registration form assessing whether the intervention is delivered and taken as intended.
Time Frame
During each patient's intervention process, every planned intervention occasion (according to the intervention guide), up to twelve months post-base line.
Title
The acceptability and value of the SEE from the perspective of the delivers
Description
Experiences of the SEE from the perspectives of the delivers, i.e., the occupational therapists, their managers and other stakeholders/key persons will be explored qualitatively in focus groups.
Time Frame
Every fourth month during the study period of two years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria A Larsson-Lund, Prof
Organizational Affiliation
Luleå University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Health Science, LTU
City
Luleå
ZIP/Postal Code
97187
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets collected and analyzed during the current project will be available from the principal investigator on reasonable request after the project is finished.
IPD Sharing Time Frame
Then the project is finished and results are published in international journals, anticipated 2024
IPD Sharing Access Criteria
The datasets will be stored anonymous and access will be possible on reasonable request after the project is finished.
Citations:
PubMed Identifier
34656173
Citation
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.
Results Reference
derived

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Strategies Empowering Activities in Everyday Life (SEE 1.0) A Web-based Occupational Therapy Intervention

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