Feasibility of the BREATHE Asthma Intervention Trial
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|ClinicalTrials.gov Identifier: NCT03036267|
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : October 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma Chronic Health Behavior||Behavioral: BREATHE Other: Attention Control Condition||Not Applicable|
Uncontrolled asthma disproportionally impacts Black and poor adults. Adherence to inhaled corticosteroids (ICS), which plays a significant role in asthma control, is relatively low in poor and minority populations. Non-adherence to ICS is associated with erroneous personal health beliefs regarding asthma care and with negative beliefs regarding ICS. Despite this, no intervention concurrently addresses beliefs regarding asthma self-care and ICS. Shared decision-making interventions have not been tested in underserved Black adults, despite this model's success in pediatric populations and in White, privately insured patients with asthma. Federally Qualified Health Centers (FQHCs) have unique challenges to helping patients achieve asthma control but are overlooked in asthma intervention research. Process evaluations are often lacking during intervention development. We will address these treatment and methodological gaps.
Objectives: This pilot study will (1) develop a brief shared decision-making intervention delivered by primary care providers (PCPs) to improve asthma control in Black adults receiving care in FQHCs; (2) evaluate the intervention's feasibility and acceptability; and (3) assess preliminary evidence of intervention effects on asthma control, ICS adherence, forced expiratory volume in one second (FEV1) - an objective lung function measure - and asthma quality of life (QOL) over a 3-month follow-up period.
Hypotheses: (1) The intervention will be feasible and acceptable, and (2) over 3 months, relative to controls, patients whose PCPs are trained in the intervention will have significant improvement on asthma control (primary outcome), ICS adherence, FEV1 and asthma QOL (secondary outcomes).
Methods: Using community-based participatory research and including a Patient Advocate, we will develop the intervention, Brief Evaluation of Asthma Therapy (BREATHE). Intervention development is guided by patient and family/support persons of asthma patients input, as well as PCP feedback. We will then conduct a randomized trial of the intervention with 8 PCPs from 2 FQHCs in Philadelphia, PA; for each PCP we will enroll 10 Black adults (N=80) with uncontrolled asthma, and with erroneous asthma care beliefs and negative ICS beliefs. PCPs will be randomized within FQHC to intervention and control; patients will be followed for 3 months. Process evaluation interviews with patients and PCPs will obtain feedback regarding intervention procedures.
Significance: This study has high public health significance because it (1) targets a highly vulnerable population for poor asthma control - Black poor adults with erroneous asthma care beliefs and with negative ICS beliefs; (2) adapts a model-based intervention to develop a novel intervention delivered by PCPs that simultaneously targets erroneous asthma beliefs and negative ICS beliefs, and which has the potential to amplify intervention effects and increase the likelihood of sustainability; and (3) includes a process evaluation, bridging the gap between science and practice, and aiding in the design of a full-scale randomized controlled trial (RCT).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial|
|Actual Study Start Date :||April 4, 2017|
|Actual Primary Completion Date :||September 22, 2017|
|Actual Study Completion Date :||September 22, 2017|
7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach
Primary care providers (PCPs) randomized to BREATHE will be trained to deliver the 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach.
Other Name: Shared decision-making using motivational interviewing
Active Comparator: Attention Control Condition
7-minute diet and exercise discussion
Other: Attention Control Condition
PCPs randomized to the control intervention will not receive any specific training. To control for contact, they will be instructed to engage in a 7-minute diet and exercise discussion as this will not confound results.
- Asthma Control Questionnaire Score [ Time Frame: Up to 3 months post-intervention ]Asthma Control Questionnaire (ACQ) score: The ACQ includes 6 items about asthma symptoms and one objective measure of pulmonary function: the forced expiratory volume 1 (FEV1). Self-report items and FEV1 are used to calculate a summary ACQ score. ACQ scores >1.5 have a positive predictive value of 88% in identifying uncontrolled asthma in clinical trials.
- Score on the Medication Adherence Record Scale-Asthma (MARS-A) [ Time Frame: Up to 3 months post-intervention ]The Medication Adherence Record Scale-Asthma (MARS-A) will be used to measure Inhaled corticosteroids (ICS) adherence. The MARS-A correlates with objective ICS adherence as measured by electronic monitoring and ICS fill/refill claims data.
- Score on the Asthma Quality of Life Questionnaire [ Time Frame: Baseline, 1-, 2- and 3-months post-intervention ]Asthma Quality of Life will be measured by the Asthma Quality of Life Questionnaire.
- Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Up to 3 months post-intervention ]The FEV1 is a physiologic measurement of airflow obstruction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036267
|United States, Pennsylvania|
|Spectrum Health Services|
|Philadelphia, Pennsylvania, United States, 19139|
|Greater Philadelphia Health Action|
|Philadelphia, Pennsylvania, United States, 19146|
|Principal Investigator:||Maureen George, PhD||Columbia University|