e-Mobile Tablet for People With Chronic Conditions

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833311
• Other study ID #: 12-14-25
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: April 2016

Study information

• Verified date: July 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Multiple Sclerosis
• Osteoarthritis
• Parkinson Disease
• Parkinson's Disease
• Sjogren's Syndrome
• Sjögren's Syndrome

Intervention

Behavioral:
• Computer Tablet Group
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
• Paper and Pencil Group
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
• Contact Control Group
Participants are prescribed an exercise program and given information on healthy eating.

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Changes From Baseline in 6-minute Walking Test		Outcomes were administered immediately before the intervention and again 6-weeks later
Secondary	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
Secondary	Changes From Baseline in Weight		Outcomes were administered immediately before the intervention and again 6-weeks later