Clinical trial NCT02833311: e-Mobile Tablet for People With Chronic Conditions
Official title: Examining the Usability of Computer Tablets to Promote Symptom Self-management and Engagement in Healthy Behaviors in Adults With Chronic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Multiple Sclerosis
Osteoarthritis
Sjögren's Syndrome
Parkinson's Disease
Keywords: Neuromusculoskeletal condition
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes From Baseline in Physical Activity
timeFrame: Outcomes were administered immediately before the intervention and again 6-weeks later
Secondary outcomes:
measure: Changes From Baseline in Self-Report Physical Function
timeFrame: Outcomes were administered immediately before the intervention and again 6-weeks later
measure: Changes From Baseline in 6-minute Walking Test
timeFrame: Outcomes were administered immediately before the intervention and again 6-weeks later
measure: Changes From Baseline in Self-Efficacy
timeFrame: Outcomes were administered immediately before the intervention and again 6-weeks later
measure: Changes From Baseline in Weight
timeFrame: Outcomes were administered immediately before the intervention and again 6-weeks later
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Matthew A Plow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plow M, Golding M. Using mHealth Technology in a Self-Management Intervention to Promote Physical Activity Among Adults With Chronic Disabling Conditions: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Dec 1;5(12):e185. doi: 10.2196/mhealth.6394.