Implementation of ACT Through Facebook for Teenagers With Asthma (C2MA)

August 29, 2020 updated by: Joseph C. Kvedar, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Partners Center for Connected Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
To assess participant engagement in the program (total number of times ACT survey taken divided by 12)
0 to 12 months
Provider engagement
Time Frame: 0 to 12 months
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
To correlate participant engagement with change in ED visits and hospital admissions.
0 to12 months
Satisfaction with intervention
Time Frame: at 12 months
To assess usability and satisfaction with the Facebook study group by administering a survey at completion of study
at 12 months
Change in knowledge about asthma
Time Frame: 0 to12 months
To assess changes in level of knowledge about asthma using the Asthma Self-Management Questionnaire, a standardized and validated survey instrument
0 to12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kamal Jethwani, MD, MPH, Partners Healthcare, Center for Connected Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 29, 2020

Last Verified

August 1, 2020

More Information

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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