Physical Activity, mHealth and Intellectual Disability - a Pilot Study

NCT ID: NCT04929106

Last Updated: 2023-01-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2022-06-01

Brief Summary

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The main objective of this pilot study is to assess distant procedures, study experiences and feasibility of a planned randomized controlled trial investigating the use of a mHealth support tool on physical activity for individuals with intellectual disability.

Detailed Description

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For individuals with intellectual disability (ID) with low physical activity (PA) levels, new methods to increase participation in physical activity are needed. Motivation for participation in PA should include both individuals with ID, family members and staff, and it should work in a supportive way to strengthen mastery experiences. Technology-based interventions have not yet been explored extensively.

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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Intellectual Disability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MHealth intervention

Tailored physical activity program with motivational mobile health support on everyday levels of physical activity

Group Type EXPERIMENTAL

mHealth support tool

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Low physical activity levels: determined with the question "How much of your leisure time have you been physically active in the last year?"
* 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

* Medical contraindications for participation in programs with increased exercise, as advised by the primary care or ID specialist physician
* High level of physical activity
* Inability to provide written informed consent and written informed consent cannot be obtained from a representative
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Royal Norwegian Ministry of Health

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Norway

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.

Reference Type BACKGROUND
PMID: 32437328 (View on PubMed)

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.

Reference Type RESULT
PMID: 31981261 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36107473 (View on PubMed)

Other Identifiers

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2016/1770

Identifier Type: -

Identifier Source: org_study_id

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