Intellectual DisabilityNCT04929106
Physical Activity, mHealth and Intellectual Disability - a Pilot Study
A study testing mHealth support tool in people with Intellectual Disability, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- mHealth support tool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNorway
- Study dates
- 7 May 2021to 1 Jun 2022
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disability - a Mixed Method Pilot Study
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.
Read the 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.
- Conditions
- Intellectual Disability
- Being tested
- mHealth support tool
- Keywords
- Intellectual Disability, Physical Activity, Technology, mHealth
- Medical subject headings
- Intellectual Disability, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth support toolDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MHealth intervention | Experimental | Tailored physical activity program with motivational mobile health support on everyday levels of physical activity Receives: Device: mHealth support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 12 weeks
Secondary outcomes (6)
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).
Measured: Baseline, 4 weeks, 12 weeks
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.
Measured: Baseline, 4 weeks, 12 weeks
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.
Measured: Baseline, 4 weeks, 12 weeks
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.
Measured: Baseline, 4 weeks, 12 weeks
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.
Measured: Baseline, 4 weeks, 12 weeks
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.
Measured: Introduced together with intervention, 1 week after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start7 May 2021
- Primary completion1 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Audny Anke, Prof. MD, Study director, University Hospital of North Norway, UiT Artic University of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929106
- Sponsor's protocol ID
- 2016/1770
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32437328Michalsen 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.
PubMed 31981261Michalsen 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.
PubMed 36107473
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disability - a Mixed Method Pilot Study
- ClinicalTrials.gov ID
- NCT04929106
- Acronym / sponsor ID
- 2016/1770
- Conditions
- Intellectual Disability
- Keywords
- Intellectual Disability, Physical Activity, Technology, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- 7 May 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 18 Jun 2021 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MHealth intervention | Experimental | Device: mHealth support toolTailored physical activity program with motivational mobile health support on everyday levels of physical activity |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| mHealth support toolThe 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. | Device | MHealth intervention |
Primary outcome
Changes in steps per day
Time frame: Baseline, 4 weeks, 12 weeks
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.
6 secondary outcomes
Minutes of moderate physical acitivty
Time frame: Baseline, 4 weeks, 12 weeks
Physical activity levels
Time frame: Baseline, 4 weeks, 12 weeks
Behavioral problems
Time frame: Baseline, 4 weeks, 12 weeks
Social support for physical activity and self-efficacy in a physical activity setting
Time frame: Baseline, 4 weeks, 12 weeks
Satisfaction with life
Time frame: Baseline, 4 weeks, 12 weeks
Goal Attainment
Time frame: Introduced together with intervention, 1 week after baseline
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 10 Jan 2023.
- Background: PubMed 32437328Michalsen 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 publication: PubMed 31981261Michalsen 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.
- Derived from this study: PubMed 36107473Michalsen 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.
- Individual participant dataSharing planned: No
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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.
Audny Anke, Prof. MD study director
University Hospital of North Norway, UiT Artic University of Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth support tool in people with Intellectual Disability, run by University Hospital of North Norway at 1 site in Norway.
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 6 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 10 Jan 2023. 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 Norway. 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?
Changes in steps per day (time frame: Baseline, 4 weeks, 12 weeks). 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 NCT04929106, which also lists 3 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 10 Jan 2023.