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Physical Activity, mHealth and Intellectual Disability - a Pilot Study

Primary Purpose

Intellectual Disability

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
mHealth support tool
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intellectual Disability focused on measuring Intellectual Disability, Physical Activity, Technology, mHealth

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of North Norway

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MHealth intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in steps per day
Objectively measured physical activity assessed by steps per day measured with a wrist-worn commercial accelerometer (Fitbit Versa, Fitbit, Inc., San Francisco, CA, USA). The device will assess level of physical activity and sedentary time. The watch will show a neutral screen during baseline and follow-up assessments. Level of physical activity will be measured for 7 days at each assessment, with a minimum of 3 consecutive days of measurement because previous research has shown that 3 days of physical activity can predict weekly level of physical activity.

Secondary Outcome Measures

Minutes of moderate physical acitivty
Secondary PA outcomes are minutes of moderate PA per day measured with a wrist-worn commercial fitness tracker (Fitbit Versa, Fitbit, Inc., San Francisco, CA, USA).
Physical activity levels
The International Physical Activity Questionnaire - Short Form, adapted to measure physical activity using proxy respondents will be used. The International Physical Activity Questionnaire - Short Form is a 7-item questionnaire that assesses PA in the past 7 days at 4 intensity levels: 1) vigorous-intensity activity, such as aerobics, 2) moderate-intensity activity, such as leisure cycling, 3) walking, and 4) sitting.
Behavioral problems
The Aberrant Behavior Checklist-Community (ABC-C) is a questionnaire designed to assess challenging behavior in children, youth, and adults with IDs. The checklist consist of 58 items divided into 5 subscales: irritability, lethargy, stereotypy, hyperactivity, and inappropriate speech. It is a proxy measure requiring knowledge of the person with ID. Each item is scored on a scale of 0-3 (3 indicating the most severity). The questionnaire has been validated for use in a Norwegian population with neurodevelopmental disabilities.
Social support for physical activity and self-efficacy in a physical activity setting
The Self-Efficacy/Social Support for Activity for persons with Intellectual Disability scale (SE/SS-AID) is a questionnaire consisting of four subscales. One subscale measures self-efficacy for overcoming barriers to leisure physical activity. The last three subscales measure social support for leisure activity from family members, care staff, and friends for individuals with intellectual disabilities. The scale has been validated for self-reporting from individuals with mild to moderate intellectual disability and for use by proxy respondents. The questionnaire will be translated into the Norwegian language using standard guidelines.
Satisfaction with life
This study will use the satisfaction with life scale developed by Bergström & Hochwälder, which was designed to assess satisfaction with the home environment and leisure time in individuals with mild to moderate intellectual disability. The scale has four factors: 1) satisfaction with housing environment, 2) satisfaction with life, 3) satisfaction with meals, and 4) satisfaction with recreational activities. Items are read aloud by a researcher and answered by participants with three response options: "good" (happy face = 2), "in between" (neutral face = 1), or "bad" (sad face = 0). In the current study, the scale is used to control for adverse effects.
Goal Attainment
Goal attainment scaling will be used to identify self-management goals that participants would like to achieve. The questionnaire will be filled out by the researcher, with participants and proxy respondents present. Goal attainment scaling involves several steps. Goals are selected by each individual, and observable behavior that reflects a degree of goal attainment is defined. The participant's pre-treatment or baseline levels are defined in terms of the goal. Five different goal attainment levels are used, ranging from "no change" to "much better than expected outcome" (numbered -2 to +2). Follow-up times for participant evaluation are set (presumably after 3 and 6 months). Goal attainment is evaluated after the defined time interval. At the end, the overall attainment score for all goals are calculated. In this study we will define up to three goals for PA.

Full Information

First Posted
June 7, 2021
Last Updated
January 9, 2023
Sponsor
University Hospital of North Norway
Collaborators
The Royal Norwegian Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT04929106
Brief Title
Physical Activity, mHealth and Intellectual Disability - a Pilot Study
Official Title
Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disability - a Mixed Method Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
The Royal Norwegian Ministry of Health

4. Oversight

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

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
Keywords
Intellectual Disability, Physical Activity, Technology, mHealth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MHealth intervention
Arm Type
Experimental
Arm Description
Tailored physical activity program with motivational mobile health support on everyday levels of physical activity
Intervention Type
Device
Intervention Name(s)
mHealth support tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in steps per day
Description
Objectively measured physical activity assessed by steps per day measured with a wrist-worn commercial accelerometer (Fitbit Versa, Fitbit, Inc., San Francisco, CA, USA). The device will assess level of physical activity and sedentary time. The watch will show a neutral screen during baseline and follow-up assessments. Level of physical activity will be measured for 7 days at each assessment, with a minimum of 3 consecutive days of measurement because previous research has shown that 3 days of physical activity can predict weekly level of physical activity.
Time Frame
Baseline, 4 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Minutes of moderate physical acitivty
Description
Secondary PA outcomes are minutes of moderate PA per day measured with a wrist-worn commercial fitness tracker (Fitbit Versa, Fitbit, Inc., San Francisco, CA, USA).
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Physical activity levels
Description
The International Physical Activity Questionnaire - Short Form, adapted to measure physical activity using proxy respondents will be used. The International Physical Activity Questionnaire - Short Form is a 7-item questionnaire that assesses PA in the past 7 days at 4 intensity levels: 1) vigorous-intensity activity, such as aerobics, 2) moderate-intensity activity, such as leisure cycling, 3) walking, and 4) sitting.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Behavioral problems
Description
The Aberrant Behavior Checklist-Community (ABC-C) is a questionnaire designed to assess challenging behavior in children, youth, and adults with IDs. The checklist consist of 58 items divided into 5 subscales: irritability, lethargy, stereotypy, hyperactivity, and inappropriate speech. It is a proxy measure requiring knowledge of the person with ID. Each item is scored on a scale of 0-3 (3 indicating the most severity). The questionnaire has been validated for use in a Norwegian population with neurodevelopmental disabilities.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Social support for physical activity and self-efficacy in a physical activity setting
Description
The Self-Efficacy/Social Support for Activity for persons with Intellectual Disability scale (SE/SS-AID) is a questionnaire consisting of four subscales. One subscale measures self-efficacy for overcoming barriers to leisure physical activity. The last three subscales measure social support for leisure activity from family members, care staff, and friends for individuals with intellectual disabilities. The scale has been validated for self-reporting from individuals with mild to moderate intellectual disability and for use by proxy respondents. The questionnaire will be translated into the Norwegian language using standard guidelines.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Satisfaction with life
Description
This study will use the satisfaction with life scale developed by Bergström & Hochwälder, which was designed to assess satisfaction with the home environment and leisure time in individuals with mild to moderate intellectual disability. The scale has four factors: 1) satisfaction with housing environment, 2) satisfaction with life, 3) satisfaction with meals, and 4) satisfaction with recreational activities. Items are read aloud by a researcher and answered by participants with three response options: "good" (happy face = 2), "in between" (neutral face = 1), or "bad" (sad face = 0). In the current study, the scale is used to control for adverse effects.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Goal Attainment
Description
Goal attainment scaling will be used to identify self-management goals that participants would like to achieve. The questionnaire will be filled out by the researcher, with participants and proxy respondents present. Goal attainment scaling involves several steps. Goals are selected by each individual, and observable behavior that reflects a degree of goal attainment is defined. The participant's pre-treatment or baseline levels are defined in terms of the goal. Five different goal attainment levels are used, ranging from "no change" to "much better than expected outcome" (numbered -2 to +2). Follow-up times for participant evaluation are set (presumably after 3 and 6 months). Goal attainment is evaluated after the defined time interval. At the end, the overall attainment score for all goals are calculated. In this study we will define up to three goals for PA.
Time Frame
Introduced together with intervention, 1 week after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audny Anke, Prof. MD
Organizational Affiliation
University Hospital of North Norway, UiT Artic University of Norway
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32437328
Citation
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.
Results Reference
background
PubMed Identifier
31981261
Citation
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.
Results Reference
result
PubMed Identifier
36107473
Citation
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.
Results Reference
derived

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Physical Activity, mHealth and Intellectual Disability - a Pilot Study

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