FibromyalgiaNCT02833311
e-Mobile Tablet for People With Chronic Conditions
A study testing Computer Tablet Group and Paper and Pencil Group in people with Fibromyalgia and Multiple Sclerosis, run by Case Western Reserve University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Fibromyalgia, Multiple Sclerosis, Osteoarthritis
- What is being tested?
- Computer Tablet Group and Paper and Pencil Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Examining the Usability of Computer Tablets to Promote Symptom Self-management and Engagement in Healthy Behaviors in Adults With Chronic Conditions
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.
Read the 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.
- Being tested
- Computer Tablet Group, Paper and Pencil Group, Contact Control Group
- Keywords
- Neuromusculoskeletal condition
- Medical subject headings
- Fibromyalgia, Multiple Sclerosis, Osteoarthritis, Sjogren's Syndrome, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Tablet GroupBehavioural
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 GroupBehavioural
Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.
Contact Control GroupBehavioural
Participants are prescribed an exercise program and given information on healthy eating.
| Study group | Role | What they receive |
|---|---|---|
| Computer Tablet Group | Active comparator | 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. Receives: Behavioral: Computer Tablet Group |
| Paper and Pencil Group | Active comparator | 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. Receives: Behavioral: Paper and Pencil Group |
| Contact Control Group | Active comparator | 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. Receives: Behavioral: Contact Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcomes were administered immediately before the intervention and again 6-weeks later
Secondary outcomes (4)
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.
Measured: Outcomes were administered immediately before the intervention and again 6-weeks later
Changes From Baseline in 6-minute Walking Test
Measured: Outcomes were administered immediately before the intervention and again 6-weeks later
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.
Measured: Outcomes were administered immediately before the intervention and again 6-weeks later
Changes From Baseline in Weight
Measured: Outcomes were administered immediately before the intervention and again 6-weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startNov 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Plow, Case Western Reserve University
- Investigators
- Matthew A Plow, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833311
- Sponsor's protocol ID
- 12-14-25
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2016
- Last updated
- 12 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29196279
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Usability of Computer Tablets to Promote Symptom Self-management and Engagement in Healthy Behaviors in Adults With Chronic Conditions
- ClinicalTrials.gov ID
- NCT02833311
- Acronym / sponsor ID
- 12-14-25
- Keywords
- Neuromusculoskeletal condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Posted 12 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computer Tablet Group | Active comparator | Behavioral: Computer Tablet GroupParticipants 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. |
| Paper and Pencil Group | Active comparator | Behavioral: Paper and Pencil GroupParticipants 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. |
| Contact Control Group | Active comparator | Behavioral: Contact Control GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer Tablet GroupA computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom. | Behavioural | Computer Tablet Group |
| Paper and Pencil GroupUse of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors. | Behavioural | Paper and Pencil Group |
| Contact Control GroupParticipants are prescribed an exercise program and given information on healthy eating. | Behavioural | Contact Control Group |
Primary outcome
Changes From Baseline in Physical Activity
Time frame: Outcomes were administered immediately before the intervention and again 6-weeks later
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.
4 secondary outcomes
Changes From Baseline in Self-Report Physical Function
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-Efficacy
Time frame: Outcomes were administered immediately before the intervention and again 6-weeks later
Changes From Baseline in Weight
Time frame: Outcomes were administered immediately before the intervention and again 6-weeks later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29196279Plow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew A Plow, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Tablet Group and Paper and Pencil Group in people with Fibromyalgia and Multiple Sclerosis, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline in Physical Activity (time frame: Outcomes were administered immediately before the intervention and again 6-weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02833311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.