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e-Mobile Tablet for People With Chronic Conditions

Primary Purpose

Fibromyalgia, Multiple Sclerosis, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer Tablet Group
Paper and Pencil Group
Contact Control Group
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring Neuromusculoskeletal condition

Eligibility Criteria

18 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Case Western Reserve University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Computer Tablet Group

Paper and Pencil Group

Contact Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Changes From Baseline in 6-minute Walking Test
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.
Changes From Baseline in Weight

Full Information

First Posted
July 12, 2016
Last Updated
July 13, 2022
Sponsor
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT02833311
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Multiple Sclerosis, Osteoarthritis, Sjögren's Syndrome, Parkinson's Disease
Keywords
Neuromusculoskeletal condition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer Tablet Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Paper and Pencil Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Contact Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer Tablet Group
Intervention Description
A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.
Intervention Type
Behavioral
Intervention Name(s)
Paper and Pencil Group
Intervention Description
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Contact Control Group
Intervention Description
Participants are prescribed an exercise program and given information on healthy eating.
Primary Outcome Measure Information:
Title
Changes From Baseline in Physical Activity
Description
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.
Time Frame
Outcomes were administered immediately before the intervention and again 6-weeks later
Secondary Outcome Measure Information:
Title
Changes From Baseline in Self-Report Physical Function
Description
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.
Time Frame
Outcomes were administered immediately before the intervention and again 6-weeks later
Title
Changes From Baseline in 6-minute Walking Test
Time Frame
Outcomes were administered immediately before the intervention and again 6-weeks later
Title
Changes From Baseline in Self-Efficacy
Description
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.
Time Frame
Outcomes were administered immediately before the intervention and again 6-weeks later
Title
Changes From Baseline in Weight
Time Frame
Outcomes were administered immediately before the intervention and again 6-weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew A Plow, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29196279
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.
Results Reference
derived

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e-Mobile Tablet for People With Chronic Conditions

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