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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01675921
Other study ID # 2012-P-000674/1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date April 2015

Study information

Verified date August 2020
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators hypothesize that at the end of the 12-month trial, teenagers regularly self-monitoring their asthma control with ACT administered through Facebook will have improved ACT scores as compared with teenagers receiving usual care.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 14 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Facebook group
Facebook will be used to remind participants to take the ACT survey once every month for 12 months.

Locations

Country Name City State
United States Partners Center for Connected Health Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Asthma Control Test (ACT) scores 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 Emergency Department (ED) visits and Hospital Admissions Compare frequency of ED and hospital admissions between the intervention and control groups 0 to 12 months
Secondary Engagement To assess participant engagement in the program (total number of times ACT survey taken divided by 12) 0 to 12 months
Secondary Provider engagement To assess provider engagement in the program (# of times reached out to patient when alerted) 0 to 12 months
Secondary Patient engagement and Emergency Department (ED) visits To correlate participant engagement with change in ED visits and hospital admissions. 0 to12 months
Secondary Satisfaction with intervention To assess usability and satisfaction with the Facebook study group by administering a survey at completion of study at 12 months
Secondary Change in knowledge about asthma To assess changes in level of knowledge about asthma using the Asthma Self-Management Questionnaire, a standardized and validated survey instrument 0 to12 months
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