Blood Pressure, Cardiovascular Diseases, Stroke
Conditions
Brief summary
The overall objective of Phone-based Intervention under Nurse Guidance after Stroke II (PINGS-2) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a theoretical-model-based, mHealth technology-centered, nurse-led, multi-level integrated approach to substantially improve longer term BP control among 500 recent stroke patients encountered at 10 hospitals in Ghana. Secondly, PINGS II seeks to develop an implementation strategy for routine integration and policy adoption of mhealth for post-stroke BP control in a LMIC setting. The investigators will leverage experience gained from the NIH Global Brain Disorders funded R21 pilot study (NS094033) to test efficacy of a refined, culturally-tailored, and potentially implementable intervention aimed at addressing the premier modifiable risk for stroke & other key variables in an under-resourced system burdened by suboptimal care & outcomes.
Interventions
BEHAVIORALPINGS 2
Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction \& stroke
OTHERStandard of Care
Standard of Care (routine post-stroke management per guidelines)
Sponsors
Northern California Institute of Research and Education
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years (stroke is commoner above this age cut-off) * male or females (sex is a biologic variable of interest) * recent stroke (within one month of symptom onset)- stroke may be ischemic or hemorrhagic based on brain imaging or diagnosed clinically using the locally validated version of the 8-item questionnaire for verifying stroke free status (8-QVSFS) when neuroimaging is not feasible * uncontrolled HTN (SBP ≥ 140 mmHg at both the last clinical encounter post-stroke and the eligibility screening visit) - SBP is used as the selection variable since most African hypertensives \<60 years have systolic or combination systolic/ diastolic HTN and for most patients, controlling SBP also results in DBP control * patients or family carers should own a basic mobile phone that can receive text/audio messages.
Exclusion criteria
\- Any condition that would limit participation in follow up assessments, such as severe cognitive impairment/dementia (MMSE ≤24).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 12 months | Target goal of \<140/90 mmHg measured at baseline, months 3, 6, 9 and 12. Measured by blinded evaluator using an automated BP monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-management | 12 months | Hypertension Self-Care Profile (HBP-SCP) Total Score, a validated measure assessing hypertension self-management across three domains: behavior, motivation, and self-efficacy. Each subscale ranges from 20 to 80, yielding a total score range of 60 to 240. Higher scores indicate better self-care. Month 12 total scores are reported. |
| Number of Cardiovascular ED Encounters and Re-hospitalizations | 12 months | To be assessed via once monthly calls to patients and/or carers over 12 months of follow up in both the PINGS and usual care groups. Patient carers in both arms will also be encouraged to contact study team within 48 hours of hospitalizations for prompt and blinded adjudication of all potential CVD ED encounters to minimize reporting bias between the two groups. |
| Number of Major Adverse Cardiovascular Events | 12 months | Major Adverse Cardiovascular events (MACE) to be assessed include recurrent stroke: fatal/ severely disabling stroke or non-fatal stroke; Coronary Artery Disease: Acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudicator by reviewing where available clinical notes supported by investigations e.g. CT scan, EKGs, review of death certificates or verbal autopsy if death occurs outside hospital. |
| Health-related Quality of Life: The Euro Quality of Life-5D Questionnaire | 12 months | The EQ-5D questionnaire,186 will assess state of health of study participants at baseline and Month 12. Scores range from 0 (the worst possible health status) to 100 (the best possible health status). |
| Medication Adherence: Hill-Bone Compliance Scale | 12 months | Hill-Bone Compliance to High Blood Pressure Therapy Scale, a validated 14-item measure assessing adherence to antihypertensive therapy across three domains: medication-taking behavior, appointment keeping, and salt intake. Total scores range from 14 to 56, with higher scores indicating worse adherence (greater non-adherence). Month 12 total scores are reported. |
| Medication Adherence: Medication Possession Ratio (MPR) | 12 months | Medication Possession Ratio (MPR), calculated as the percentage of days covered by filled antihypertensive prescriptions over 12 months. Values range from 0% to 100%, with higher values indicating better adherence. Month 12 MPR values are reported. |
Countries
Ghana
Participant flow
Recruitment details
Recruitment Period: First participant enrolled: October 23, 2020 Last participant enrolled: April 21, 2023 Last participant completed follow-up: April 5, 2024 Recruitment Locations: 10 hospitals in Ghana (3 tertiary, 2 district, 5 primary level). Urban, peri-urban, and rural populations. Recruitment Setting: Participants identified during acute stroke hospitalization or follow-up clinics. Stroke confirmed by CT (when feasible) or validated stroke-free questionnaire (QVSFS).
Pre-assignment details
Screened: 905 potential participants. Excluded (n=405): Did not meet eligibility criteria: 243 Declined to participate: 162 Randomized: 500 participants
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58 Years STANDARD_DEVIATION 11 |
| Alcohol Use (Current) | 28 Participants |
| Antihypertensive Medications at Baseline ACE Inhibitors | 51 Participants |
| Antihypertensive Medications at Baseline Alpha Blockers | 7 Participants |
| Antihypertensive Medications at Baseline Antiplatelets | 148 Participants |
| Antihypertensive Medications at Baseline ARBs | 230 Participants |
| Antihypertensive Medications at Baseline Betablockers | 34 Participants |
| Antihypertensive Medications at Baseline Calcium Channel Blockers | 200 Participants |
| Antihypertensive Medications at Baseline Diuretics | 56 Participants |
| Antihypertensive Medications at Baseline Methyldopa | 40 Participants |
| Antihypertensive Medications at Baseline Statins | 362 Participants |
| Cigarette Smoking | 45 Participants |
| Diabetes Mellitus | 98 Participants |
| Diastolic Blood Pressure | 96 mmHg STANDARD_DEVIATION 15 |
| Health Literacy Score | 9 score on a scale |
| Hemoglobin A1C | 6 Percent |
| Hill-Bone Adherence Score | 52 score on a scale |
| Hyperlipidemia | 78 Participants |
| Modified Rankin Scale | 2 score on a scale |
| NIHSS Stroke Severity | 3 score on a scale |
| Overweight/Obesity | 128 Participants |
| Quality of Life EQ-5D | 70 score on a scale |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Ghana | 500 Participants |
| Sex: Female, Male Female | 116 Participants |
| Sex: Female, Male Male | 141 Participants |
| Stroke Type Hemorrhagic Transformation | 8 Participants |
| Stroke Type ICH | 45 Participants |
| Stroke Type Ischemic | 164 Participants |
| Stroke Type Untyped | 32 Participants |
| Systolic BP | 157 mmHg STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 14 / 244 | 14 / 256 |
| other Total, other adverse events | 0 / 244 | 0 / 256 |
| serious Total, serious adverse events | 27 / 244 | 18 / 256 |
Outcome results
None listed