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Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center (MOMMI3CFCM)

Primary Purpose

Medication Adherence, Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
caremessage
Sponsored by
Landon Pediatric Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Medication Adherence focused on measuring adherence, cystic fibrosis

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Absence of a parent/guardian or unwillingness to provide permission;
  • Potential participant declines to provide assent; and
  • Transplant patients.

Sites / Locations

  • Pediatric Diagnostic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Interactive Mobile Health Information

Usual care

Arm Description

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.

Usual care - clinic education, medication refills without reminders, appointments without reminders

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
FEV1 in LPM
Measure of pulmonary function
Body mass index
kg/meters squared

Full Information

First Posted
December 24, 2015
Last Updated
May 3, 2019
Sponsor
Landon Pediatric Foundation
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03052231
Brief Title
Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center
Acronym
MOMMI3CFCM
Official Title
Evaluating the Feasibility of Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Landon Pediatric Foundation
Collaborators
AbbVie

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Cystic Fibrosis
Keywords
adherence, cystic fibrosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interactive Mobile Health Information
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care - clinic education, medication refills without reminders, appointments without reminders
Intervention Type
Device
Intervention Name(s)
caremessage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Scheduled appointments attended
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Knowledge of disease Questionnaire
Description
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.
Time Frame
Six Months
Title
FEV1 in LPM
Description
Measure of pulmonary function
Time Frame
6 months
Title
Body mass index
Description
kg/meters squared
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Absence of a parent/guardian or unwillingness to provide permission; Potential participant declines to provide assent; and Transplant patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Landon, MD
Organizational Affiliation
Landon Pediatric Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Diagnostic Center
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Share with iCAN
Citations:
PubMed Identifier
21458391
Citation
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.
Results Reference
background
Citation
Quittner A et al. Chest 2011 (4_MeetingAbstracts):908A
Results Reference
background
Citation
Imperial College of London. iCAN Self---Management Technology: Helping Patients to Medical Appointments. CID 00884448, May 5, 2014
Results Reference
background
PubMed Identifier
16679071
Citation
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.
Results Reference
background
PubMed Identifier
19119348
Citation
Taddeo 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.
Results Reference
background
Citation
QSR International, Victoria, Australia, 2015
Results Reference
background

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Interactive Mobile Health Information to Enhance Patient Care at a Cystic Fibrosis Center

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