Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With HF (TARGET)
Trialing an automated medication dispensing device (AMDD) to improve medication adherence in patients with heart failure.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Targeted Intervention to Improve Medication Adherence in Cognitively Impaired Patients With Heart Failure|
- Efficacy of AMDD to improve medication adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD
- Feasibility of AMDD to improve medication adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]Ease of the setup of the AMDD will be evaluated, as well as patient and family acceptance of the AMDD
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study
Device: Automated Medication Dispensing Device
A pre-filled medication dispensing machine with a safety phone call if doses are missed
Other Name: AMDD
- Objective. Primary objective of this study is to assess feasibility and effectiveness of an automated medication dispensing device (AMDD) in a convenience sample of veteran outpatients with heart failure who also have cognitive impairment.
- Research Design. This is a single center prospective interventional study using patients as their own controls. As the main objective of this study is to assess feasibility of using new technology, the study is not powered to an endpoint - however, effectiveness of the device will be measured in this small sample by assessing medication adherence at baseline ("usual care") and after using the device.
- Methodology. We plan to enroll 50 patients at heart failure clinic at the VA Loma Linda Healthcare System. This convenience sample will be enrolled from cardiology clinics. Main inclusion criteria will be history of heart failure (clinical diagnosis) and some degree of cognitive impairment as determined on the screening test (Saint Louis University Mental Status Examination). Patients who have diagnosed dementia, require a caregiver, or who do not manage their own medications, will be excluded.
Patients will be evaluated at baseline ("usual care") and after intervention with AMDD for medication adherence if they qualify after initial 30-day pill count. After baseline clinic visits, data collection and pill count, patients who qualify will be set up with the AMDD at their home. The AMDD will be pre-filled with patient's medications once a month for four months, with the first month being spent with the patients familiarizing themselves to the AMDD. At the end of each of the subsequent three months with the AMDD, a "pill count" will be performed by the home health nurse (by counting the number medications that remain in the AMDD from the previous month). Generic demographic, clinical, and cost data will also be collected throughout the study, as well as data for feasibility.
Collected data will be presented in a descriptive manner (feasibility analysis) and analytical manner (comparing medication adherence at baseline and after the intervention). We will also explore relationship between the extent of cognitive impairment and medication adherence. Main emphasis of the study is to collect adequate data to allow us to design and plan a larger study using AMDD.
|Contact: Christopher J Firek, BA||(909) 825-7084 ext email@example.com|
|Contact: Elena Perez||(909) 982-7084 ext firstname.lastname@example.org|
|United States, California|
|VA Medical Center, Loma Linda||Recruiting|
|Loma Linda, California, United States, 92357|
|Contact: Helme Silvet, MD 909-583-6097 Helme.Silvet@va.gov|
|Contact: Kristi Morrow (909) 958-6156 email@example.com|
|Principal Investigator: Helme Silvet, MD|
|Principal Investigator:||Helme Silvet, MD||VA Medical Center, Loma Linda|