AsthmaC2MANCT01675921
Implementation of ACT Through Facebook for Teenagers With Asthma
A study testing Facebook group in people with Asthma, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Facebook group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Disability or co-morbidity precluding regular access to the internet.
- Cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Partners Center for Connected Health
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Facebook group
- Keywords
- Asthma, Facebook, teenagers, ACT
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facebook groupOther
Facebook will be used to remind participants to take the ACT survey once every month for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Facebook group | Experimental | 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. Receives: Other: Facebook group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 to 12 months
Secondary outcomes (6)
Emergency Department (ED) visits and Hospital Admissions
Compare frequency of ED and hospital admissions between the intervention and control groups
Measured: 0 to 12 months
Engagement
To assess participant engagement in the program (total number of times ACT survey taken divided by 12)
Measured: 0 to 12 months
Provider engagement
To assess provider engagement in the program (# of times reached out to patient when alerted)
Measured: 0 to 12 months
Patient engagement and Emergency Department (ED) visits
To correlate participant engagement with change in ED visits and hospital admissions.
Measured: 0 to12 months
Satisfaction with intervention
To assess usability and satisfaction with the Facebook study group by administering a survey at completion of study
Measured: at 12 months
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
Measured: 0 to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Kamal Jethwani, MD, MPH, Principal investigator, Partners Healthcare, Center for Connected Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675921
- Sponsor's protocol ID
- 2012-P-000674/1
- Acronym
- C2MA
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2012
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of ACT Through Facebook for Teenagers With Asthma
- ClinicalTrials.gov ID
- NCT01675921
- Acronym / sponsor ID
- C2MA / 2012-P-000674/1
- Conditions
- Asthma
- Keywords
- Asthma, Facebook, teenagers, ACT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Facebook group | Experimental | Other: Facebook groupParticipants 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- Disability or co-morbidity precluding regular access to the internet.
- Cognitive impairment.
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 |
|---|---|---|
| Facebook groupFacebook will be used to remind participants to take the ACT survey once every month for 12 months. | Other | Facebook group |
Primary outcome
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
6 secondary outcomes
Emergency Department (ED) visits and Hospital Admissions
Time frame: 0 to 12 months
Engagement
Time frame: 0 to 12 months
Provider engagement
Time frame: 0 to 12 months
Patient engagement and Emergency Department (ED) visits
Time frame: 0 to12 months
Satisfaction with intervention
Time frame: at 12 months
Change in knowledge about asthma
Time frame: 0 to12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
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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.
Kamal Jethwani, MD, MPH principal investigator
Partners Healthcare, Center for Connected Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facebook group in people with Asthma, run by Massachusetts General Hospital 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 7 inclusion and 2 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 1 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Asthma Control Test (ACT) scores (time frame: 0 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2020.