- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07527598
Health Web 1.0: A Web-based Occupational Therapy Group Intervention for Older Adults
The goal of this feasibility study is to evaluate the design, content and delivery of Health Web 1.0, a web-based occupational therapy group intervention supporting older adults' social participation and meaningful activities in daily life.
More specifically, this feasibility study aims to:
- Determine the acceptability and adherence of the Health Web among older adults and occupational therapists.
- Determine the perceived values, benefits, harms and unintended consequences of the Health Web among older adults.
- Explore changes experienced by older adults and the potential outcomes of social participation and meaningful activities in daily life.
The participants will be invited to participate in a web-based group intervention including thematic sessions over a period of seven weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The demographic changes associated with a growing ageing population worldwide imply a need for a shift in the health and social care system and a need for new innovations and interventions to support active and healthy ageing. Important aspects of healthy ageing, emphasized by the World Health Organization (WHO), are possibilities for social participation and the ability to create and maintain social relationships. In Sweden, there is an ongoing transition in the health care system towards personalized and integrated care, in which people are encouraged to take greater responsibility for their health. Additionally, digital solutions have been identified as an opportunity to offer new interventions to meet the needs of this transition. For professionals such as occupational therapists, this implies a need to increase the use of new digital interventions that address healthy ageing and support social participation. According to occupational therapy research, digital technology has the potential to support older adults' social participation and reduce experiences of loneliness. Thus, developing health promotion interventions that support the development of strategies for social participation when ageing is an important concern within occupational therapy. To address this background, a web-based occupational therapy group intervention, the Health Web, has been developed, with a focus on strategies for social participation and meaningful activities in daily life to support healthy ageing.
This feasibility study will be conducted using a pretest and posttest design without a control group to evaluate feasibility and potential results. Qualitative and quantitative data will be collected concurrently in a convergent mixed-method design. The combination of data provides enables a comprehensive evaluation of feasibility. Health Web 1.0 is a health promoting intervention targeting older adults 65+ and is delivered by Occupational Therapists in municipality primary healthcare settings in northern Sweden. This feasibility study provides important information to further evaluate and refine the intervention programme prior to larger-scale testing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Luleå, Sweden, 97187
- Luleå University of Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 65 years or older
- living in ordinary housing
- experience with a changed life situation that can influence possibilities for social participation
- having access to a computer or tablet and access to and experience with using the internet and e-mail
- able to assimilate information and express themselves through speech.
Exclusion Criteria:
- living in a short-term unit or nursing home or having an ongoing application to a nursing home
- having a disease or condition that affects the ability to provide informed consent and participate in data collection and the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The older adults will receive the Health Web intervention provided by an Occupational therapist
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The Health Web intervention will be delivered by an Occupational therapist (OT) via a digital communication platform.
The intervention includes two introduction sessions, five theme sessions and a follow-up session.
Each theme session includes a short educational video followed by a reflection assignment and a group meeting.
The intervention aims to support older adults in becoming aware of, reflecting on, using and developing strategies for social participation and meaningful activities in daily life.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occupational Balance Questionnaire (OBQ)
Time Frame: The outcome measure is completed within 2 weeks before the intervention is initiated, within 2 weeks after the intervention is completed and 3 months after the intervention is completed.
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The OBQ consists of 11 items that are graded on a 4-point ordinal scale from 0-3; these items range from "completely" disagree to "completely" agree and 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.
Used to capture the satisfaction with, and the variation in daily activities.
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The outcome measure is completed within 2 weeks before the intervention is initiated, within 2 weeks after the intervention is completed and 3 months after the intervention is completed.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The general self-efficacy scale (S-GSE)
Time Frame: The outcome measure is completed within 2 weeks before the intervention is initiated, within 2 weeks after the intervention is completed and 3 months after the intervention is completed.
|
Each item consists of a statement about one's ability to cope with demands in life.
The participant rates each item on a scale from 1-4, where 1 represents "disagree" and 4 represents "strongly agree" with the statement; thus, a higher score (total score 10-40) indicates greater self-efficacy.
Used to measure self-perceived self-efficacy
|
The outcome measure is completed within 2 weeks before the intervention is initiated, within 2 weeks after the intervention is completed and 3 months after the intervention is completed.
|
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A measure of strategies for social participation
Time Frame: The outcome measure is completed within 2 weeks before the intervention is initiated, within 2 weeks after the intervention is completed and 3 months after the intervention is completed.
|
The developed measure consists of 24 items, each being a statement about strategies used for social participation.
Each item is rated on a scale from 0-3, where 0 represents "disagree" and 3 represents "strongly agree" with the statement; thus, a higher score (total score 0-72) indicates greater use of strategies.
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The outcome measure is completed within 2 weeks before the intervention is initiated, within 2 weeks after the intervention is completed and 3 months after the intervention is completed.
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Intervention-specific registration forms for older adults
Time Frame: Completed by older adults within 1 week after each theme session 1-5.
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These registration forms contain questions about content and delivery for which answers are self-reported on a 5-point Likert scale ranging from very low agreement (1) to very high agreement (5).
Older adults will score their level of agreement as follows: a) gain of new and useful knowledge, b) value of reflection assignments, c) value of and engagement in group discussions, and d) use of the digital communication platform.
Space is also provided in the registration form to write their own comments.
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Completed by older adults within 1 week after each theme session 1-5.
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Intervention-specific registration forms for Occupational therapists
Time Frame: Completed by the OTs within 1 week after each theme session 1-5.
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These registration forms contain questions about delivery for which answers are self-reported on a 5-point Likert scale ranging from very low agreement (1) to very high agreement (5).
The OTs will score their level of agreement with the following: a) compliance with the intervention guide, b) achieving the purpose of the session, c) perceived support from the intervention guide, d) confidence in the role as a group leader, e) satisfactory management of the digital communication platform and f) satisfactory management of the digital communication platform by older adults.
Space is also provided in the registration form to write their own comments.
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Completed by the OTs within 1 week after each theme session 1-5.
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Individual semi-structured interviews with older adults
Time Frame: Within 2 weeks before the intervention is initiated, within 2 weeks after the intervention is completed and 3 months after the intervention is completed.
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The preintervention questions aim to capture their current social participation, their motivators for participation and their expectations of participation in the intervention.
Directly after the programme is completed, the interviews will explore experiences of the different parts of the intervention process and the perceived value of the intervention for their social participation and meaningful activities in daily life.
The interview performed after three months will explore how progress has been made toward the established goals and plan.
Furthermore, potential changes that have occurred in everyday life, as well as perspectives on future social participation.
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Within 2 weeks before the intervention is initiated, within 2 weeks after the intervention is completed and 3 months after the intervention is completed.
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Individual semi-structured interviews with Occupational therapists
Time Frame: Within 2 weeks before the intervention is initiated and within 2 weeks after the intervention is completed.
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The questions for the interview before delivery will explore the interest in and motivation to deliver the intervention, expectations of conducting a digital intervention and their role as a group leader.
In the interviews after, the questions will explore experiences of delivering the intervention, compliance with the intervention guide, experiences of their role as a group leader, the digital delivery and time used, and the relevance of the content and the overall value of the intervention.
Also, how the education programme prepared them for the delivery of the intervention.
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Within 2 weeks before the intervention is initiated and within 2 weeks after the intervention is completed.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anneli Nyman, Luleå Tekniska Universitet
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Health Web - 633940
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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