StrokeNCT04588116
Strategies Empowering Activities in Everyday Life (SEE 1.0) a Web-based Occupational Therapy Intervention
A study testing Strategies Empowering activities in Everyday life (SEE 1.0) in people with Stroke, run by Luleå Tekniska Universitet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Strategies Empowering activities in Everyday life (SEE 1.0)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2020to 30 Jun 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Strategies Empowering activities in Everyday life (SEE 1.0)
- Keywords
- Stroke, self-management,, activities of daily life,, life-style intervention,, web-based rehabilitation,, tele-rehabilitation,, digital e- health solutions,, occupational therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategies Empowering activities in Everyday life (SEE 1.0)Behavioural
Also called Strategies Empowering activities in Everyday life (SEE 1.0) A web-based occupational therapy intervention for people with stroke
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Strategies Empowering activities in Everyday life (SEE 1.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to four- and twelve-months post-base line
Secondary outcomes (4)
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.
Measured: Change from baseline to four- and twelve-months post-base line
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.
Measured: Change from baseline to four- and twelve-months post-base line
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.
Measured: Change from baseline to four- and twelve-months post-base line
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
Measured: Change from baseline to four- and twelve-months post-base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Nov 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luleå Tekniska Universitet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Larsson Lund, Luleå Tekniska Universitet
- Investigators
- Maria A Larsson-Lund, Prof, Principal investigator, Luleå University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588116
- Sponsor's protocol ID
- SEE-685304
- Status last verified
- Aug 2024
- First submitted
- 2 Oct 2020
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 40033363Larsson-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.
PubMed 34656173
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04588116
- Acronym / sponsor ID
- SEE-685304
- Conditions
- Stroke
- Keywords
- Stroke, self-management,, activities of daily life,, life-style intervention,, web-based rehabilitation,, tele-rehabilitation,, digital e- health solutions,, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Luleå Tekniska UniversitetUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A feasibility study with a pre-test post-test design without control group embedded in a mix-method approach.
| Arm | Type | Receives |
|---|---|---|
| The web- based occupational therapy intervention SEE | Experimental | Behavioral: Strategies Empowering activities in Everyday life (SEE 1.0)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strategies Empowering activities in Everyday life (SEE 1.0)Also: Strategies Empowering activities in Everyday life (SEE 1.0) A web-based occupational therapy intervention for people with strokeThe 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. | Behavioural | The web- based occupational therapy intervention SEE |
Primary outcome
The profiles of occupational engagement (POES)
Time frame: Change from baseline to four- and twelve-months post-base line.
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)
Time frame: Change from baseline to four- and twelve-months post-base line
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).
Time frame: Change from baseline to four- and twelve-months post-base line
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.
4 secondary outcomes
Life satisfaction questionnaire (Lisat-11)
Time frame: Change from baseline to four- and twelve-months post-base line
The general self- efficacy scale (S-GSE)
Time frame: Change from baseline to four- and twelve-months post-base line
Work ability index (WAI)
Time frame: Change from baseline to four- and twelve-months post-base line
Stroke Impact Scale, participation (SIS)
Time frame: Change from baseline to four- and twelve-months post-base line
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Derived from this study: PubMed 40033363Larsson-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.
- Derived from this study: PubMed 34656173Larsson-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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria A Larsson-Lund, Prof principal investigator
Luleå University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategies Empowering activities in Everyday life (SEE 1.0) in people with Stroke, run by Luleå Tekniska Universitet 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 8 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 3 Sep 2024. 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?
The profiles of occupational engagement (POES) (time frame: Change from baseline to four- and twelve-months post-base line.). The study lists 3 primary outcomes in all. 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 NCT04588116, 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 3 Sep 2024.