N/A
Completed N=99
Veterans Intensive Personalized Treatment in Heart Failure
Source: ClinicalTrials.gov NCT01404988 ↗Enrolled (actual)
99
Serious AEs
10.1%
Results posted
May 2015
Primary outcomePrimary: Medication Adherence (Refill Compliance for All HF Medications) — 0.94; 0.97; 0.99 proportion of refill compliance — p=0.1
Summary
In the VIP (Veterans Intensive Personalized) Treatment in Heart Failure Study we will assess 2 novel interventions to enhance adherence and improve quality of life in veterans with heart failure. This 3-arm randomized controlled trial will base one active arm on how ready patients are for change in terms of diet and medication adherence and will tailor the intervention based on this. The other active arm will also assess how ready patients are for change, but will also include tailoring based on availability of environment resources, such as proximity to health food stores or social support, to further tailor the intervention. The last active arm is simply an attention group where patients will receive general health counseling in addition to background care that all patients receive. The overarching hypothesis is that the tailored interventions will lower heart failure (HF) recurrence and improve quality of life by better medication and diet adherence compared to attention placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Adherence (Refill Compliance for All HF Medications) |
0.94; 0.97; 0.99 | 0.1 |
| SECONDARY Adherence to ACE Inhibitors and ARB |
0.98; 1.0; 1.0 | .3 |
| SECONDARY Adherence to Beta Blockers |
0.95; 0.97; 1.0 | 0.03 sig |
| SECONDARY Self-reported Medication Adherence |
2; 4; 1; 9; 11; 8 | 0.60 |
Eligibility Criteria
Inclusion Criteria
- Men and women (21 years) with history and clinical findings of chronic, stable HF of NYHA functional class I (previously symptomatic/now asymptomatic), II, or III.
- They must have an available phone and 2 clinic visits in the previous 1.5 years.
Exclusion Criteria
- Patients with poor short-term survival (< 1 year)
- recent major surgery (< 3 months)
- temporarily in the area
- or those unable to provide consent will be excluded.
- Patients excluded and reason for exclusion will be recorded.
Data sourced from ClinicalTrials.gov (NCT01404988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.