e-Mobile Tablet for People With Chronic Conditions

Study Overview
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Brief Summary
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Maintaining a healthy diet and engaging in routine physical activity may help decrease severity of symptoms, prevent secondary conditions, and slow functional decline in people with disabling neuromusculoskeletal conditions. However, people with these conditions face many health barriers to engaging in healthy behaviors. With the advent of portable technologies, such as smart phones, tablets and PDAs, there is a need to explore whether these technologies can help people with disabling conditions to stay motivated and overcome barriers to engaging in healthy behaviors.

Detailed Description
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The overarching goal of this mixed methods, comparative effectiveness randomized controlled pilot study is to evaluate whether goal setting, self-monitoring, and barrier management using a computer tablet can increase physical activity behavior, improve nutritional habits, and promote health-related quality of life in people with disabling neuromusculoskeletal conditions. Our hypothesis is that, in comparison to the standard care contact control group, participants in both the tablet group and the paper and pencil group will yield significant improvements in healthy behaviors,with the tablet group yielding significantly larger increases.

Official Title
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Examining the Usability of Computer Tablets to Promote Symptom Self-management and Engagement in Healthy Behaviors in Adults With Chronic Conditions

Conditions
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Fibromyalgia, Multiple Sclerosis, Osteoarthritis, Sjögren's Syndrome, Parkinson's Disease

Intervention / Treatment
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* Behavioral: Computer Tablet Group
* Behavioral: Paper and Pencil Group
* Behavioral: Contact Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician-confirmed diagnosis of a neuro-musculoskeletal condition or disease of the nerves, muscles, and/or bones that results in functional limitations Physician consent to engage in home exercise/physical activity program Regularly inactive (i.e., engaging in 90 minutes or less of purposeful physical activity each week) Scoring ≤17 mental composite and ≤16 physical composite on the Global Health Questionnaire. Have internet access (i.e., home, library or other WiFi location) Exclusion Criteria: If the only disabling condition reported is not considered a neuro-musculoskeletal disease Have hand-motor function impairments that would limit use of the tablet Often engage in healthy eating habits Are frequent fallers (i.e., more than 3 falls per month) Have a diagnoses of chronic obstructive pulmonary disease, serious mental health disorder, chronic heart failure, myocardial infarction, and other unstable/severe cardiovascular conditions, and uncontrolled diabetes mellitus (e.g., admission to the hospital within the past 6 months for uncontrolled diabetes) Have severe cognitive deficits Reports consistently tracking and monitoring health behaviors Unable to effectively use the tablet technology during the pre-intervention usability demonstration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Computer Tablet Group<br>Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet. | Behavioral: Computer Tablet Group<br>* A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.<br>|
| Active Comparator: Paper and Pencil Group<br>Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary. | Behavioral: Paper and Pencil Group<br>* Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.<br>|
| Active Comparator: Contact Control Group<br>Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics. | Behavioral: Contact Control Group<br>* Participants are prescribed an exercise program and given information on healthy eating.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Physical Activity | Physical Activity and Disability Survey-Revised was administered to assess physical activity behavior. Scores can range from -2.7493 to 3.3671. Higher scores on the Physical Activity and Disability Survey-Revised indicates increased physical activity levels. | Outcomes were administered immediately before the intervention and again 6-weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Self-Report Physical Function | Patient Reported Outcome Measurement information System (PROMIS) Physical Function (PF) was used to measure self-report physical function. Measures are scored on a T-score metric. High scores indicate more of the concept being measured. A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. | Outcomes were administered immediately before the intervention and again 6-weeks later | 
| Changes From Baseline in 6-minute Walking Test |  | Outcomes were administered immediately before the intervention and again 6-weeks later | 
| Changes From Baseline in Self-Efficacy | Exercise Confidence Survey was used to measure self-efficacy. The survey asks about confidence in sticking to an exercise program and making time for exercise. This is a 12 item questionnaire and scores ranges from 1 to 60. A higher score indicates increased confidence to engage in exercise. | Outcomes were administered immediately before the intervention and again 6-weeks later | 
| Changes From Baseline in Weight |  | Outcomes were administered immediately before the intervention and again 6-weeks later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromusculoskeletal condition