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e-Mobile Tablet for People With Chronic Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833311
First Posted: July 14, 2016
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthew Plow, Case Western Reserve University
  Purpose
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.

Condition Intervention
Fibromyalgia Multiple Sclerosis Osteoarthritis Sjögren's Syndrome Parkinson's Disease Behavioral: Computer Tablet Group Behavioral: Paper and Pencil Group Behavioral: Standard Treatment Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Examining the Usability of Computer Tablets to Promote Symptom Self-management and Engagement in Healthy Behaviors in Adults With Chronic Conditions

Resource links provided by NLM:


Further study details as provided by Matthew Plow, Case Western Reserve University:

Primary Outcome Measures:
  • Changes from baseline in Physical Activity and Disability Survey-Revised [ Time Frame: Outcomes were administered immediately before the intervention and again 6-weeks later ]

Secondary Outcome Measures:
  • Changes from baseline in Patient Reported Outcomes Measurement Information System (PROMIS-Computer Adaptive Tests) [ Time Frame: Outcomes were administered immediately before the intervention and again 6-weeks later ]
  • Changes from baseline in 6-minute Walking Test [ Time Frame: Outcomes were administered immediately before the intervention and again 6-weeks later ]
  • Changes from baseline in Self-Management-Self-Efficacy questionnaires [ Time Frame: Outcomes were administered immediately before the intervention and again 6-weeks later ]
  • Changes from baseline in Body Mass Index (BMI) [ Time Frame: Outcomes were administered immediately before the intervention and again 6-weeks later ]

Enrollment: 46
Study Start Date: November 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: Computer Tablet Group
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.
Active Comparator: Paper and Pencil Group
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Behavioral: Paper and Pencil Group
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.
Active Comparator: Standard Treatment Control Group
Participants are prescribed an exercise program and given information on healthy eating.
Behavioral: Standard Treatment Control Group
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833311


Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Matthew A Plow, PhD Case Western Reserve University
  More Information

Responsible Party: Matthew Plow, Project Scientist, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT02833311     History of Changes
Other Study ID Numbers: 12-14-25
First Submitted: July 12, 2016
First Posted: July 14, 2016
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Matthew Plow, Case Western Reserve University:
Neuromusculoskeletal condition

Additional relevant MeSH terms:
Osteoarthritis
Parkinson Disease
Multiple Sclerosis
Fibromyalgia
Sjogren's Syndrome
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Neuromuscular Diseases
Arthritis, Rheumatoid
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases