Hypertension, Medication Adherence
Conditions
Brief summary
The overall objective of this project is to utilize the PRECEDE-PROCEED framework to conduct transdisciplinary, translational implementation research focused on improving medication adherence for hypertension control. The central hypothesis is that peer delivery of medications integrated with HIT (PT4A) will be effective in improving hypertension medication adherence, contributing to improved blood pressure among patients with uncontrolled hypertension in western Kenya. This study record will focus on Sub-Aim 2.2: a pilot of the intervention and a survey questionnaire with patients, peers, and clinical staff to evaluate feasibility. The investigators will evaluate impact on systolic blood pressure, medication adherence, and fidelity of implementation. The investigators will also create a retrospective comparator (control) group of CDM patients, through querying AMRS, matched by sex, age, location and initial blood pressure level. The investigators will then use their recorded blood pressure over a comparable period of up to 1 year and to allow for comparison to the blood pressure changes observed in the patients enrolled in the PT4A program to help understand the magnitude and variance of the intervention effects.
Interventions
BEHAVIORALPeer Delivery of Medications
The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities
To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥ 18 years old * Enrolled in the AMPATH CDM PRogram * Have uncontrolled hypertension (defined as systolic blood pressures ≥ 140 or diastolic blood pressure ≥ 90)
Exclusion criteria
* Acute illness requiring immediate medical attention * Terminal illness * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Mean Change in Systolic Blood Pressure (SBP) | Baseline, Month 12 | — |
| Pill Count Adherence Ratio | Month 12 | Proportion of prescribed doses taken over a 1-month time period. |
| Number of Confirmed Medication Deliveries | Month 12 | Confirmed medication delivery will be documented by patient e-signature. |
| Number of Peer Completions of HIT Form | Month 12 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Enrolled in the AMPATH CDM Program Peer Delivery of Medications: The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities
Health Information Technology (HIT) Platform: To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence. | 95 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Residential relocation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Patients Enrolled in the AMPATH CDM Program |
|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 10.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 95 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Kenya | 95 participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 101 |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 1 / 101 |
Outcome results
Primary
Absolute Mean Change in Systolic Blood Pressure (SBP)
Time frame: Baseline, Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Enrolled in the AMPATH CDM Program | Absolute Mean Change in Systolic Blood Pressure (SBP) | 11.5 millimeters of mercury (mmHg) | Standard Deviation 23.9 |
Primary
Number of Confirmed Medication Deliveries
Confirmed medication delivery will be documented by patient e-signature.
Time frame: Month 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Enrolled in the AMPATH CDM Program | Number of Confirmed Medication Deliveries | 992 Deliveries |
Primary
Number of Peer Completions of HIT Form
Time frame: Month 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Enrolled in the AMPATH CDM Program | Number of Peer Completions of HIT Form | 999 Completed forms |
Primary
Pill Count Adherence Ratio
Proportion of prescribed doses taken over a 1-month time period.
Time frame: Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Enrolled in the AMPATH CDM Program | Pill Count Adherence Ratio | 0.99 Proportion of prescribed doses | Standard Deviation 0.08 |