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

CompletedNot a drug-phase studyMS (type not specified)NCT02833311

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Computer Tablet Group
  • Paper and Pencil Group
  • Contact Control Group

Results by group

Changes From Baseline in Physical Activity

Outcomes were administered immediately before the intervention and again 6-weeks later

GroupValueIntervalNumber analysed
Computer Tablet Group0.36 units on a scale0.77 (Standard Deviation)13
Paper and Pencil Group0.31 units on a scale1.01 (Standard Deviation)15
Contact Control Group0.43 units on a scale0.68 (Standard Deviation)15
Computer Tablet Group0.76 units on a scale0.92 (Standard Deviation)13
Paper and Pencil Group0.55 units on a scale1.15 (Standard Deviation)15
Contact Control Group0.36 units on a scale0.61 (Standard Deviation)15

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Computer Tablet Group153 (20.0%)
Paper and Pencil Group163 (18.8%)
Standard Treatment Control Group151 (6.7%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Changes From Baseline in Physical Activity

    Outcomes were administered immediately before the intervention and again 6-weeks later

    Physical function

Other measures (4)

  • Changes From Baseline in Self-Report Physical Function

    Outcomes were administered immediately before the intervention and again 6-weeks later

    Quality of life (reported by participants)
  • Changes From Baseline in 6-minute Walking Test

    Outcomes were administered immediately before the intervention and again 6-weeks later

    Walking and mobility
  • Changes From Baseline in Self-Efficacy

    Outcomes were administered immediately before the intervention and again 6-weeks later

    Physical function
  • Changes From Baseline in Weight

    Outcomes were administered immediately before the intervention and again 6-weeks later

Who could take part

MS (type not specified) · 18 to 76

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Nov 2013

    2. Main results due

      Apr 2016

    3. Finished

      Apr 2016

    4. Results posted

      May 2023

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