Medication AdherenceMOMMI3CFCMNCT03052231
Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center
A study testing caremessage in people with Medication Adherence and Cystic Fibrosis, run by Landon Pediatric Foundation at 1 site in United States.
Trial summary
Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, Cystic Fibrosis
- What is being tested?
- caremessage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Feb 2017
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with diagnosis of Cystic fibrosis at all ages;
- Their associated CF Center professionals;
- Their associated family;
- CF patients that should be treated with one or more of these chronic medications: Tobi (Tobramycin), (Colistin), Pulmozyme (Dornase Alpha), Hypertonic Saline (HS), Creon (pancreatic enzymes), AquaADEKs (Multivitamin);
- Patients willing to participate in a trial;
- Presence of a parent/guardian capable of providing informed consent; and
- Patients attending CF clinic at least once every 12 months.
Who cannot join
- Absence of a parent/guardian or unwillingness to provide permission;
- Potential participant declines to provide assent; and
- Transplant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Diagnostic Center
Ventura, California, 93003
About this study
Official title: Evaluating the Feasibility of Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center
Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. Advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. The investigators propose to evaluate a systematic yet technically simple approach to linking treatment and feedback components to enhance adherence in a real-work CF clinic setting that treats a significant minority patient population.
This is the first trial assessing the impact of a collaborative active intervention program of a multi disciplinary team in improving adherence to specific chronic medications and improving clinical outcomes in CF patients. The PI has implemented the texting service (Caremessage.org) with COPD and diabetes patients. The content will be modified to provide both English and Spanish language content relevant to these participants and their standard treatment protocols.
Read the detailed description
This study will evaluate the effectiveness of an interactive mobile health information service in supporting clinic staff (i.e., nurse practitioners, case managers and care coordinators) at a Cystic Fibrosis Center clinic to connect with patients and create conversations around behavior-centered goals. The interactive mobile health information service has been designed to supplement the standard of care by supporting patient-empowerment strategies through:
- educating participants,
- encouraging behavior change, and
- promoting adherence with their treatment protocols.
The project will adapt the iCAN program content as an educational tool to be incorporated in the educational material. iCAN is an electronic platform aimed to provide an engaging environment for diabetic outpatients to self-manage, gain control over their health, and ultimately adhere to their medical appointments and regimen. Similar to diabetes, CF is an all-encompassing chronic disease that requires coordinated efforts among patients, caregivers, and health-care providers across treatment adherence, nutrition, lifestyle choices, and social support systems. Central to the mobile health information service is the interactive and personalized text-based message system that delivers actionable and tailored health content to participants: office visit appointment reminders; medication adherence reminders; and general health education messages. While a number of technically sophisticated applications exist, our approach will involve a less sophisticated and complex approach. Our primary objective is to get the information to the patients, some of whom are members of lower income minority communities. If "simple" interventions prove effective, then the groundwork will have been laid for considering more tailored albeit complex systems.
- Conditions
- Medication Adherence, Cystic Fibrosis
- Being tested
- caremessage
- Keywords
- adherence, cystic fibrosis
- Medical subject headings
- Medication Adherence, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caremessageDevice
Central to the mobile health information service is the interactive and personalized text-based message system that delivers actionable and tailored health content to participants: office visit appointment reminders; medication adherence reminders; and general health education messages.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Mobile Health Information | Active comparator | Receives Interactive Mobile Health Information via caremessage. EAI staff focus group content will include qualitative descriptions of their experiences with training and actual use of the Caremessages.org service, as well as to elicit comments about contributing features and other mitigating or enhancing factors of the intervention's implementation, outreach and promotion, and integration into workflow practices. Receives: Device: caremessage |
| Usual care | No intervention | Usual care - clinic education, medication refills without reminders, appointments without reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Scheduled appointments attended
Secondary objectives include evaluating program processes that enhance participant use of the system: 1) to receive responses to specific questions; 2) to track their individual progress towards achieving health goals, and; 3) to respond to system prompts to self-report data in the interactive component related to their actions or behaviors, e.g. RSVP to appointment reminders, self-management behaviors related to medication adherence, and self-management behaviors related to the achieving health goals. Processes involving program management and impact on barriers to treatment delivery by clinic staff, treating physicians and parents will also be evaluated.
Measured: Six months
Secondary outcomes (3)
Knowledge of disease Questionnaire
Secondary objectives include evaluating program processes that enhance participant use of the system: 1) to receive responses to specific questions; 2) to track their individual progress towards achieving health goals, and; 3) to respond to system prompts to self-report data in the interactive component related to their actions or behaviors, e.g. RSVP to appointment reminders, self-management behaviors related to medication adherence, and self-management behaviors related to the achieving health goals. Processes involving program management and impact on barriers to treatment delivery by clinic staff, treating physicians and parents will also be evaluated.
Measured: Six Months
FEV1 in LPM
Measure of pulmonary function
Measured: 6 months
Body mass index
kg/meters squared
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startMar 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landon Pediatric Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Chris Landon, MD, Principal investigator, Landon Pediatric Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052231
- Sponsor's protocol ID
- LandonPF
- Acronym
- MOMMI3CFCM
- Status last verified
- May 2019
- First submitted
- 24 Dec 2015
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Share with iCAN
Publications
Eakin MN, Bilderback A, Boyle MP, Mogayzel PJ, Riekert KA. Longitudinal association between medication adherence and lung health in people with cystic fibrosis. J Cyst Fibros. 2011 Jul;10(4):258-64. doi: 10.1016/j.jcf.2011.03.005. Epub 2011 Mar 31.
PubMed 21458391Quittner A et al. Chest 2011 (4_MeetingAbstracts):908A
Imperial College of London. iCAN Self---Management Technology: Helping Patients to Medical Appointments. CID 00884448, May 5, 2014
Modi AC, Lim CS, Yu N, Geller D, Wagner MH, Quittner AL. A multi-method assessment of treatment adherence for children with cystic fibrosis. J Cyst Fibros. 2006 Aug;5(3):177-85. doi: 10.1016/j.jcf.2006.03.002. Epub 2006 May 5.
PubMed 16679071Taddeo D, Egedy M, Frappier JY. Adherence to treatment in adolescents. Paediatr Child Health. 2008 Jan;13(1):19-24. doi: 10.1093/pch/13.1.19.
PubMed 19119348QSR International, Victoria, Australia, 2015
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center
- ClinicalTrials.gov ID
- NCT03052231
- Acronym / sponsor ID
- MOMMI3CFCM / LandonPF
- Conditions
- Medication Adherence, Cystic Fibrosis
- Keywords
- adherence, cystic fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Landon Pediatric FoundationUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 14 Feb 2017 (actual)
- 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.
Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. Advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. The investigators propose to evaluate a systematic yet technically simple approach to linking treatment and feedback components to enhance adherence in a real-work CF clinic setting that treats a significant minority patient population.
This is the first trial assessing the impact of a collaborative active intervention program of a multi disciplinary team in improving adherence to specific chronic medications and improving clinical outcomes in CF patients. The PI has implemented the texting service (Caremessage.org) with COPD and diabetes patients. The content will be modified to provide both English and Spanish language content relevant to these participants and their standard treatment protocols.
Detailed description
This study will evaluate the effectiveness of an interactive mobile health information service in supporting clinic staff (i.e., nurse practitioners, case managers and care coordinators) at a Cystic Fibrosis Center clinic to connect with patients and create conversations around behavior-centered goals. The interactive mobile health information service has been designed to supplement the standard of care by supporting patient-empowerment strategies through:
- educating participants,
- encouraging behavior change, and
- promoting adherence with their treatment protocols.
The project will adapt the iCAN program content as an educational tool to be incorporated in the educational material. iCAN is an electronic platform aimed to provide an engaging environment for diabetic outpatients to self-manage, gain control over their health, and ultimately adhere to their medical appointments and regimen. Similar to diabetes, CF is an all-encompassing chronic disease that requires coordinated efforts among patients, caregivers, and health-care providers across treatment adherence, nutrition, lifestyle choices, and social support systems. Central to the mobile health information service is the interactive and personalized text-based message system that delivers actionable and tailored health content to participants: office visit appointment reminders; medication adherence reminders; and general health education messages. While a number of technically sophisticated applications exist, our approach will involve a less sophisticated and complex approach. Our primary objective is to get the information to the patients, some of whom are members of lower income minority communities. If "simple" interventions prove effective, then the groundwork will have been laid for considering more tailored albeit complex systems.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Mobile Health Information | Active comparator | Device: caremessageReceives Interactive Mobile Health Information via caremessage. EAI staff focus group content will include qualitative descriptions of their experiences with training and actual use of the Caremessages.org service, as well as to elicit comments about contributing features and other mitigating or enhancing factors of the intervention's implementation, outreach and promotion, and integration into workflow practices. |
| Usual care | No intervention | –Usual care - clinic education, medication refills without reminders, appointments without reminders |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with diagnosis of Cystic fibrosis at all ages;
- Their associated CF Center professionals;
- Their associated family;
- CF patients that should be treated with one or more of these chronic medications: Tobi (Tobramycin), (Colistin), Pulmozyme (Dornase Alpha), Hypertonic Saline (HS), Creon (pancreatic enzymes), AquaADEKs (Multivitamin);
- Patients willing to participate in a trial;
Key exclusion criteria (3 listed)
- Absence of a parent/guardian or unwillingness to provide permission;
- Potential participant declines to provide assent; and
- Transplant patients.
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 |
|---|---|---|
| caremessageCentral to the mobile health information service is the interactive and personalized text-based message system that delivers actionable and tailored health content to participants: office visit appointment reminders; medication adherence reminders; and general health education messages. | Device | Interactive Mobile Health Information |
Primary outcome
Number of Scheduled appointments attended
Time frame: Six months
Secondary objectives include evaluating program processes that enhance participant use of the system: 1) to receive responses to specific questions; 2) to track their individual progress towards achieving health goals, and; 3) to respond to system prompts to self-report data in the interactive component related to their actions or behaviors, e.g. RSVP to appointment reminders, self-management behaviors related to medication adherence, and self-management behaviors related to the achieving health goals. Processes involving program management and impact on barriers to treatment delivery by clinic staff, treating physicians and parents will also be evaluated.
3 secondary outcomes
Knowledge of disease Questionnaire
Time frame: Six Months
FEV1 in LPM
Time frame: 6 months
Body mass index
Time frame: six 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 7 May 2019.
- Background: PubMed 21458391Eakin MN, Bilderback A, Boyle MP, Mogayzel PJ, Riekert KA. Longitudinal association between medication adherence and lung health in people with cystic fibrosis. J Cyst Fibros. 2011 Jul;10(4):258-64. doi: 10.1016/j.jcf.2011.03.005. Epub 2011 Mar 31.
- BackgroundQuittner A et al. Chest 2011 (4_MeetingAbstracts):908A
- BackgroundImperial College of London. iCAN Self---Management Technology: Helping Patients to Medical Appointments. CID 00884448, May 5, 2014
- Background: PubMed 16679071Modi AC, Lim CS, Yu N, Geller D, Wagner MH, Quittner AL. A multi-method assessment of treatment adherence for children with cystic fibrosis. J Cyst Fibros. 2006 Aug;5(3):177-85. doi: 10.1016/j.jcf.2006.03.002. Epub 2006 May 5.
- Background: PubMed 19119348Taddeo D, Egedy M, Frappier JY. Adherence to treatment in adolescents. Paediatr Child Health. 2008 Jan;13(1):19-24. doi: 10.1093/pch/13.1.19.
- BackgroundQSR International, Victoria, Australia, 2015
- Individual participant dataSharing planned: No. Share with iCAN
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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.
Chris Landon, MD principal investigator
Landon Pediatric Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caremessage in people with Medication Adherence and Cystic Fibrosis, run by Landon Pediatric Foundation 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 3 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 7 May 2019. 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?
Number of Scheduled appointments attended (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03052231, which also lists 6 linked publications.
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 7 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.