Physical Activity, mHealth and Intellectual Disability - a Pilot Study
NCT ID: NCT04929106
Last Updated: 2023-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2021-05-07
2022-06-01
Brief Summary
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Detailed Description
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The study objective is to assess feasibility of procedures for a distant, COVID-19-secure intervention, study pre-treatment expectations and experiences of participants and their caregivers. In addition, the study will explore the effectiveness of an individually tailored PA program with motivational mobile health support on everyday levels of PA, goal setting and self-efficacy in a PA setting for youth and adults with intellectual disabilities.
The current protocol concerns the conducting of a mixed method pilot study to test intervention procedures of a planned complex randomised controlled trial, with steps per day as main outcome. Ten participants with intellectual disability are included. Assessment are at baseline, follow-up after 4 weeks and 12 weeks. Goal attainment scale will be used together with the introduction of an activity planner application named Active Leisure as the intervention. Feasibility and acceptance of procedures, activity measures and questionnaires are assessed.
The present trial will investigate how modern technology and e-health can be used in the promotion of PA in individuals with IDs. The study has potentially important implications for both individuals with IDs and their support networks. If successful, the project will provide a simple and accessible solution for promoting PA in individuals with IDs.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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MHealth intervention
Tailored physical activity program with motivational mobile health support on everyday levels of physical activity
mHealth support tool
The final app is named Active Leisure and consists of an advanced activity planner based on the platform developed by the ideal company Smart Cognition AS. The app offers different interface options (symbols only, easy to read text, plain text, and read aloud). The activity planner will mostly be used by the individual with IDs and a support person (caregiver or health care provider). After completing an activity, a simple reward is available (e.g., a smiling face or to share a picture with other users of the app). The use of tailored communication through personalization: the use of individuals first name in the activity planner, adaptation: individually chosen activities, adjusted communication (symbols, easy-to-read text or plain text), preparation and planning, and feedback: rewarding and positive feedback (after activities have been performed) is expected to increase motivation, and thereby lead to higher levels of PA.
Interventions
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mHealth support tool
The final app is named Active Leisure and consists of an advanced activity planner based on the platform developed by the ideal company Smart Cognition AS. The app offers different interface options (symbols only, easy to read text, plain text, and read aloud). The activity planner will mostly be used by the individual with IDs and a support person (caregiver or health care provider). After completing an activity, a simple reward is available (e.g., a smiling face or to share a picture with other users of the app). The use of tailored communication through personalization: the use of individuals first name in the activity planner, adaptation: individually chosen activities, adjusted communication (symbols, easy-to-read text or plain text), preparation and planning, and feedback: rewarding and positive feedback (after activities have been performed) is expected to increase motivation, and thereby lead to higher levels of PA.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of intellectual disability (mild, moderate, severe, or profound)
* Aged 16-60 years old
* Ability to participate in the intervention
* Ability to walk with or without support
* Able to provide written informed consent or written informed consent can be obtained from a representative
Exclusion Criteria
* High level of physical activity
* Inability to provide written informed consent and written informed consent cannot be obtained from a representative
16 Years
60 Years
ALL
No
Sponsors
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The Royal Norwegian Ministry of Health
OTHER
University Hospital of North Norway
OTHER
Responsible Party
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Principal Investigators
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Audny Anke, Prof. MD
Role: STUDY_DIRECTOR
University Hospital of North Norway, UiT Artic University of Norway
Locations
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University Hospital of North Norway
Tromsø, , Norway
Countries
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References
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Michalsen H, Wangberg SC, Hartvigsen G, Jaccheri L, Muzny M, Henriksen A, Olsen MI, Thrane G, Jahnsen RB, Pettersen G, Arntzen C, Anke A. Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 29;9(6):e19213. doi: 10.2196/19213.
Michalsen H, Wangberg SC, Anke A, Hartvigsen G, Jaccheri L, Arntzen C. Family members and health care workers' perspectives on motivational factors of participation in physical activity for people with intellectual disability: A qualitative study. J Intellect Disabil Res. 2020 Apr;64(4):259-270. doi: 10.1111/jir.12716. Epub 2020 Jan 24.
Michalsen H, Wangberg SC, Hartvigsen G, Henriksen A, Pettersen G, Jaccheri L, Jahnsen RB, Thrane G, Arntzen C, Anke A. mHealth Support to Stimulate Physical Activity in Individuals With Intellectual Disability: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2022 Sep 15;11(9):e37849. doi: 10.2196/37849.
Other Identifiers
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2016/1770
Identifier Type: -
Identifier Source: org_study_id
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