- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675921
Implementation of ACT Through Facebook for Teenagers With Asthma (C2MA)
Study Overview
Detailed Description
The investigators propose to administer the Asthma Control Test (ACT), a clinically validated and reliable measure of asthma control, to a pediatric pulmonary patient population, using novel channels to improve usage of the tool and health outcomes. The investigators will administer ACT to patients using Facebook to monitor asthma control and notify clinicians when there is deterioration of control.
The goal is to improve health outcomes in patients with asthma by measuring adherence to the use of monitoring tool, follow-up visits to their specialist, and hospitalization/Emergency Department (ED) visits. To achieve this, the investigators will use a novel technology platform that is simple, secure, private and easily scalable to other relevant sites and groups, without the need for additional investment. Currently, patients take the ACT survey only during their scheduled office appointments. The aim of the study is to increase the use of ACT to monitor patients who see a pediatric pulmonologist to promote regular self-monitoring.
ACT is a short symptom-based survey consisting of 5 questions, validated in English and Spanish. Participants will receive reminders on Facebook every month to login to the study website to complete the ACT survey therefore allowing patients to easily take the survey on a regular basis, and receive reminders and educational content in the media spaces they already inhabit. Participants would receive reminders and links in the same way they would receive other reminders or notifications from Facebook. The system will rate asthma control and send patients and their specialist notification of status if it reaches critical levels, defined as a score of 14 or lower on the ACT survey. This will be a system generated notification, based on a protocol developed in conjunction with the physicians at the Massachusetts General Hospital (MGH) pediatric pulmonary department.
The intervention will study the efficacy of electronic social networks in engaging teenagers in their asthma control over time, using a simple but effective symptom-based survey tool. Both patients and providers would receive notifications in case of deteriorating control, which could result in early intervention and lead to better clinical outcomes by prompting timely intervention by the clinician. The Center for Connected Health (CCH) will work with the MGH Department of Pulmonology, as well as the Pediatric Asthma group at Partners Community HealthCare Inc. (PCHI) to enroll ambulatory teenagers with asthma in the research study for one year.
120 participants will be enrolled and randomly assigned to one of two groups.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Partners Center for Connected Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Teenagers age 14-17 years inclusive.
- Diagnosis of asthma by a PCP or a specialist at a Partners affiliated hospital/health center.
- Access to computer with internet.
- Active email account
- Fluency in English (spoken and written)
- Be on controller medications (such as: inhaled corticosteroids, cromolyn sodium and nedocromil sodium, long-acting beta-agonists (LABAs), and methylxanthines) to control asthma and prevent symptoms from developing.
- Have an active account on Facebook
Exclusion Criteria:
- Disability or co-morbidity precluding regular access to the internet.
- Cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Participants will continue to receive medical care from their doctor as usual. Participants will have access to this study website at the start and at the end of the study. |
|
|
Experimental: Facebook group
Participants will continue to receive medical care from their doctor as usual. Participants will have access to the study website at all times throughout the study. Participants will have access to the secret study group on Facebook for 12 months. Participants will take the ACT survey once a month for 12 months. |
Facebook will be used to remind participants to take the ACT survey once every month for 12 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Control Test (ACT) scores
Time Frame: 0 to 12 months
|
Assess the effect of the Facebook intervention (also referred to as "Connect 2 My ACT" intervention on trends of ACT scores in teenagers diagnosed with asthma
|
0 to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency Department (ED) visits and Hospital Admissions
Time Frame: 0 to 12 months
|
Compare frequency of ED and hospital admissions between the intervention and control groups
|
0 to 12 months
|
|
Engagement
Time Frame: 0 to 12 months
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To assess participant engagement in the program (total number of times ACT survey taken divided by 12)
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0 to 12 months
|
|
Provider engagement
Time Frame: 0 to 12 months
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To assess provider engagement in the program (# of times reached out to patient when alerted)
|
0 to 12 months
|
|
Patient engagement and Emergency Department (ED) visits
Time Frame: 0 to12 months
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To correlate participant engagement with change in ED visits and hospital admissions.
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0 to12 months
|
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Satisfaction with intervention
Time Frame: at 12 months
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To assess usability and satisfaction with the Facebook study group by administering a survey at completion of study
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at 12 months
|
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Change in knowledge about asthma
Time Frame: 0 to12 months
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To assess changes in level of knowledge about asthma using the Asthma Self-Management Questionnaire, a standardized and validated survey instrument
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0 to12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kamal Jethwani, MD, MPH, Partners Healthcare, Center for Connected Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-P-000674/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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