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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer Tablet Group | Behavioral | A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Outcomes were administered immediately before the intervention and again 6-weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew A Plow, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29196279 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Paper and Pencil Group | Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors. 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. |
| FG002 | Standard Treatment Control Group | Participants are prescribed an exercise program and given information on healthy eating. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Outcomes were administered immediately before the intervention and again 6-weeks later |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Plow, Ph.D. | Case Western Reserve University | 216-368-8969 | map208@case.edu |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009103 | Multiple Sclerosis |
| D010003 | Osteoarthritis |
| D012859 | Sjogren's Syndrome |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D010209 | Paper |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Paper and Pencil Group | Behavioral | Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors. |
|
| Contact Control Group | Behavioral | Participants are prescribed an exercise program and given information on healthy eating. |
|
| Outcomes were administered immediately before the intervention and again 6-weeks later |
| Changes From Baseline in 6-minute Walking Test | 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. | Outcomes were administered immediately before the intervention and again 6-weeks later |
| Changes From Baseline in Weight | Outcomes were administered immediately before the intervention and again 6-weeks later |
| BG001 | Paper and Pencil Group | Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors. 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. |
| BG002 | Standard Treatment Control Group | Participants are prescribed an exercise program and given information on healthy eating. 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Paper and Pencil Group | Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors. 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. |
| OG002 | Contact Control Group | Participants are prescribed an exercise program and given information on healthy eating. 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Outcomes were administered immediately before the intervention and again 6-weeks later |
|
|
|
| Secondary | Changes From Baseline in 6-minute Walking Test | Posted | Mean | Standard Deviation | meters | Outcomes were administered immediately before the intervention and again 6-weeks later |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Outcomes were administered immediately before the intervention and again 6-weeks later |
|
|
|
| Secondary | Changes From Baseline in Weight | 3 participants (2 in the computer tablet group and 1 in the paper and pencil group) were missing weight data for posttest timepoint. These participants were removed from analysis. | Posted | Mean | Standard Deviation | kg | Outcomes were administered immediately before the intervention and again 6-weeks later |
|
|
|
| 3 |
| 15 |
| 0 |
| 15 |
| EG001 | Paper and Pencil Group | Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors. 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. | 3 | 16 | 0 | 16 |
| EG002 | Standard Treatment Control Group | Participants are prescribed an exercise program and given information on healthy eating. 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. | 1 | 15 | 0 | 15 |
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| D009422 |
| Nervous System Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D001172 | Arthritis, Rheumatoid |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
|
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