Self-management in Heart Failure Clinical Trial
Official title:
A Randomized Study of the Efficacy of a New Intervention for Medication Adherence in Chronic Illness: Medications, Meaning and Me (The 3-M Study)
| Verified date | October 2014 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Purpose of the study - The purpose of this study is to develop and evaluate the efficacy of
a new, theoretically based intervention to improve medication adherence in persons with HF.
The hypotheses include:
Hypothesis I. Poorly adherent patients with symptomatic HF who receive the intervention
(n=40) will be more adherent to medicines during the12-month intervention than a control
group (n=40) of poorly adherent patients with symptomatic HF.
Hypothesis II. Poorly adherent patients with symptomatic HF who receive the intervention
(n=40) will have fewer hospital readmissions (HR) and emergency department (ED) visits
during the 12-month intervention than a control group of poorly adherent patients with
symptomatic HF.
Study Activities and population - A prospective, randomized controlled design will be used
to pilot test the efficacy of a new intervention to promote adherence to the medication
regimen in chronic heart failure in the clinical setting. The initial development and
feasibility testing of the intervention is complete (Preliminary Work, Section 4.5).
Patients with HF symptom exacerbation (n = 80) who exhibit high likelihood of poor
adherence, as determined by a validated screening measure, the Medication Adherence Scale
(MAS)89 at baseline assessment, will be recruited and randomized to receive the intervention
or usual care with attention control. Medication adherence, symptom frequency and intensity,
hospital readmissions (HR) and emergency department (ED) visits will be assessed in both
groups at 3, 6 and 12-month clinic visits. The intervals between visits are considered
sufficient to minimize sensitization bias to psychometric measures. Longitudinal measurement
is required to evaluate the magnitude of change in adherence and symptom-related events
occurring over time. Efficacy will be measured as improved adherence (primary outcome) and
decreased HR and ED visits (secondary outcomes) in the intervention group as compared to the
attention control group at 12 months. The study will close when all patients have had a
12-month post-enrollment clinic visit.
Data Analysis & Safety/Risk Considerations - The investigators will use generalized linear
models to test the primary and secondary hypotheses (McCullagh and Nelder, 1989). Logistic
generalizations of the traditional, multivariate GLM are appropriate when the dependent
variable is binary and the probability of an event is modeled, as is the case with adherence
in this study. When the dependent variable is a count, a commonly used generalized model
uses the natural logarithm of the count, as with re-hospitalizations and ED visits in this
study. In compliance with NIH guidelines for data safety and monitoring activities, a number
of quality control steps will be used to ensure the on-going safety of participants and the
scientific integrity of this feasibility intervention study. The proposed study poses only
very minimal risks to participants. All participants will receive usual care. Participation
in the study will not replace patients' regular health care attention. Data safety will be
monitored by the PI, the Data Safety Officer (Dr. Karl Swedberg), and the study
co-investigators. Any adverse events will be reported immediately to the Duke IRB and the
NIH.
Data Safety. First, a project database will be constructed, using participant ID numbers and
including all demographic, pre- and post-intervention history and all assessment materials.
A separate file, cross-referencing participant identification with project ID numbers, will
be maintained with access limited to the PI or a designated member of the investigative
team.
| Status | Completed |
| Enrollment | 87 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - > 18 years old - symptomatic heart failure - telephone required Exclusion Criteria: - heart failure due to congenital etiology - patients who cannot provide self-care |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | National Institute of Nursing Research (NINR) |
Granger BB, Ekman I, Hernandez AF, Sawyer T, Bowers MT, DeWald TA, Zhao Y, Levy J, Bosworth HB. Results of the Chronic Heart Failure Intervention to Improve MEdication Adherence study: A randomized intervention in high-risk patients. Am Heart J. 2015 Apr;169(4):539-48. doi: 10.1016/j.ahj.2015.01.006. Epub 2015 Jan 14. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in medication adherence | Nurse-observed pill count, the primary measure of adherence, was collected at baseline (0), 3, 6, and 12 months. | baseline (0), 3, 6, and 12 months | No |
| Primary | change in medication adherence based on the MAS | The study team also collected the Morisky Medication Adherence Scale (MAS) at baseline (0), 3, 6, and 12 months. | baseline (0), 3, 6, and 12 months | No |
| Secondary | change in belief in medications | Horne "Belief in Medications Questionnaire" (BMQ) was collected at baseline (0), 3,6, and 12 months | baseline (0), 3, 6, and 12 months | No |
| Secondary | change in symptom frequency | count of patient-reported symptom onset was collected at baseline (0), 3,6, and 12 months | baseline (0), 3,6, and 12 months | No |
| Secondary | change in hospital readmissions | Readmissions were reviewed with patients at baseline (0), 3, 6, and 12 months. | baseline (0), 3, 6, and 12 months | No |
| Secondary | change in Emergency Department visits | Emergency department visits were reviewed with patients at baseline (0), 3, 6 and 12 months. | baseline (0), 3, 6 and 12 months | No |
| Secondary | change in satisfaction with Information about Medicines (SIMS) | The questionnaire "satisfaction with information about medicines" was collected at baseline (0), 3, 6, and 12 months | baseline (0), 3, 6, and 12 months | No |
| Secondary | change in Kansas City Cardiomyopathy Questionnaire (KCCQ) | The questionnaire "KCCQ" was collected at baseline (0), 3, 6, and 12 months | baseline (0), 3, 6, and 12 months | No |