Stroke
Conditions
Keywords
Stroke
Brief summary
The proposed 2-phase project will first refine the TargetEd MAnageMent (TEAM) intervention to ensure acceptability across a broad range of Ugandans at risk for stroke and then test the effects of TEAM in reducing stroke risk in a 3-site, prospective, 6-month randomized controlled trial (RCT).
Detailed description
In Phase 1 of the project, stakeholder's advisory board (SAB) will be convened across 3 Ugandan sites. The SAB will be composed of up to 15 relevant stakeholders including 3 stroke survivors, 3 individuals with multiple stroke risk factors as defined above, 3 family members, 3 clinicians and 3 administrators who practice in the proposed study enrollment sites. The purpose of the SAB is to refine the TEAM intervention content to meet the needs of patients and professional healthcare stakeholders and suggest how TEAM might best be incorporated into clinical workflow, as well as give guidance and feedback on recruitment methods and advertisements. Phase 2 of the project will be conducted across 3 Ugandan sites that will enroll a representative sample of Ugandans at risk for stroke (Kiruddu, Nsambya and Mbarara Hospitals and their associated outpatient clinics). In the RCT portion of the study, 246 participants will be randomized at baseline on a 1:1 basis to receive either TEAM (N= 123) or enhanced treatment as usual (ETAU) (N=123) and will be followed for a total of 6 months. Since stroke is a moderately long-term health outcome (years to decades) that typically occurs in the presence of one or more stroke risk factors, the project will focus on testing whether TEAM can modify well-established short-term biomarkers that predict stroke risk, specifically BP control, serum cholesterol and blood glucose control. Secondary outcomes of interest include additional stroke risk biomarkers, (HDL, LDL, triglycerides) diet, exercise, use of alcohol and tobacco, stroke knowledge/attitudes, stress, and treatment adherence with risk-reducing medications. We will also explore associations of age, gender, urban vs. rural residential status and stroke history (prior vs. no previous stroke) on TEAM outcomes. To help inform future scale-up should RCT findings be positive, we will assess barriers and facilitators to TEAM implementation using both qualitative and quantitative methods.
Interventions
BEHAVIORALTEAM
TEAM is informed by principles of social cognitive theory TEAM uses nurses and peer educator dyads (PEDs) composed of patients and their care partners to co-deliver an intervention intended to help reduce future stroke risk. Team begins with one 60-minute 1:1 orientation session, in which the nurse and PED meet with the patient and his/her care partner. This is followed by 6 hour-long group sessions with 6-8 patients and their care partners held approximately weekly. The first orientation session will be done approximately 1 week post baseline, followed by group sessions were done at 2, 4, 6, 8, 10 and 12 weeks post-baseline.
BEHAVIORALETAU
ETAU will consist of an orientation visit with a nurse who will provide patient-education materials on stroke risk adapted from the American Heart Association materials and cover common risk factors such as hypertension, obesity, high salt/high fat diet and diabetes. Patients will also receive basic written information in their language of preference and tailored to the reading level of most patients at the clinic. Patients will be offered the opportunity to bring a family member with them to this visit who may also ask questions and who can assist them with understanding written materials for those with limited literacy. The nurse in ETAU will then follow-up with participants with a series of 9 brief phone calls spaced out over the course of 6 months (approximately every 2 weeks during months 1 and 2, then approximately monthly thereafter). Content will reinforce materials provided in the orientation visit and the nurse will be available to answer questions that may arise.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Fogarty International Center of the National Institute of Health
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age range: ≥ 18 years * At risk for stroke defined by the following: 1. High systolic BP defined as ≥ 140 mmHg assessed on at least 2 occasions at least 3 days apart and either criterion b or c as noted below: 2. At least 1 other modifiable stroke risk factor including: diabetes, hyperlipidemia, obesity, smoking, problem alcohol use or sedentary lifestyle. Problem alcohol use for screening purposes will be assessed with questions on frequency, type of alcohol and quantity consumed. Participants will be classified as engaging in potential problem alcohol use if they exceed the recommended level for safe alcohol intake i.e. more than 3 drinks on average every time they drink, or if they undertook binge drinking (i.e. more than 3 drinks on one occasion in the one month preceding the evaluation). 3. History of stroke or transient ischemic attack within the past 5 years * Able to participate in group sessions
Exclusion criteria
* Individuals who are unable or unwilling to provide written informed consent * Individuals who have sickle-cell disease * Females who are pregnant or lactating * Individuals with dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Systolic Blood Pressure (BP) at 6 Months | Baseline and 6 months | Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure |
Countries
Uganda
Participant flow
Pre-assignment details
Phase 1 stakeholders helped to refine the intervention content, suggest how TEAM might best be incorporated into clinical workflow, and gave guidance/feedback on recruitment methods. They are considered enrollees. Peer educator dyads, composed of patients who are at risk for stroke and their care partners, are considered enrollees. Enrollment number and number of participants Started/Completed represent the number of individual participants Nurse educators are not enrollees.
Participants by arm
| Arm | Count |
|---|---|
| TargEted MAnageMent Intervention (TEAM) This arm will receive the experimental intervention, TargEted MAnageMent Intervention (TEAM)
TEAM: TEAM is informed by principles of social cognitive theory TEAM uses nurses and peer educator dyads (PEDs) composed of patients and their care partners to co-deliver an intervention intended to help reduce future stroke risk. Team begins with one 60-minute 1:1 orientation session, in which the nurse and PED meet with the patient and his/her care partner. This is followed by 6 hour-long group sessions with 6-8 patients and their care partners held approximately weekly. The first orientation session will be done approximately 1 week post baseline, followed by group sessions were done at 2, 4, 6, 8, 10 and 12 weeks post-baseline. | 122 |
| Enhanced Treatment as Usual (ETAU) This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).
ETAU: ETAU will consist of an orientation visit with a nurse who will provide patient-education materials on stroke risk adapted from the American Heart Association materials and cover common risk factors such as hypertension, obesity, high salt/high fat diet and diabetes. Patients will also receive basic written information in their language of preference and tailored to the reading level of most patients at the clinic. Patients will be offered the opportunity to bring a family member with them to this visit who may also ask questions and who can assist them with understanding written materials for those with limited literacy. The nurse in ETAU will then follow-up with participants with a series of 9 brief phone calls spaced out over the course of 6 months (approximately every 2 weeks during months 1 and 2, then approximately monthly thereafter). Content will reinforce materials provided in the orientation visit and the nurse will be available to answer questions that may arise. | 125 |
| Phase 1 Stakeholders Stakeholders helped to refine the TEAM intervention content to meet the needs of patients and professional healthcare stakeholders and suggest how TEAM might best be incorporated into clinical workflow, as well as give guidance and feedback on recruitment methods and advertisements. | 15 |
| Phase 2: TargEted MAnageMent Intervention (TEAM) - Peer Educators Peer Educators helped to co-deliver the TEAM intervention along with Peer Educators Care Partners and Nurses | 7 |
| Phase 2: TargEted MAnageMent Intervention (TEAM) - Care Partners Peer Educator Care Partners helped to co-deliver the TEAM intervention along with Peer Educators and Nurses | 7 |
| Total | 276 |
Baseline characteristics
| Characteristic | Total | Enhanced Treatment as Usual (ETAU) | Phase 1 Stakeholders | Phase 2: TargEted MAnageMent Intervention (TEAM) - Peer Educators | Phase 2: TargEted MAnageMent Intervention (TEAM) - Care Partners | TargEted MAnageMent Intervention (TEAM) |
|---|---|---|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 12 | 55.7 years STANDARD_DEVIATION 12.5 | 50.6 years STANDARD_DEVIATION 13.41 | 51.6 years STANDARD_DEVIATION 12 | 39.4 years STANDARD_DEVIATION 14.8 | 55.2 years STANDARD_DEVIATION 11.6 |
| Currently employed/working | 161 Participants | 79 Participants | — | — | — | 82 Participants |
| Educational Level None | 18 Participants | 8 Participants | 0 Participants | 0 Participants | — | 10 Participants |
| Educational Level Primary | 120 Participants | 67 Participants | 1 Participants | 1 Participants | — | 51 Participants |
| Educational Level Secondary | 95 Participants | 36 Participants | 7 Participants | 1 Participants | — | 51 Participants |
| Educational Level Tertiary | 36 Participants | 14 Participants | 7 Participants | 5 Participants | — | 10 Participants |
| Family Stroke History | 50 Participants | 25 Participants | — | — | — | 25 Participants |
| Marital Status Married | 148 Participants | 56 Participants | 11 Participants | 5 Participants | — | 76 Participants |
| Marital Status Separated/Divorced/Widowed | 104 Participants | 61 Participants | 2 Participants | 2 Participants | — | 39 Participants |
| Marital Status Single | 17 Participants | 8 Participants | 2 Participants | 0 Participants | — | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 276 Participants | 125 Participants | 15 Participants | 7 Participants | 7 Participants | 122 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Uganda | 276 Participants | 125 Participants | 15 Participants | 7 Participants | 7 Participants | 122 Participants |
| Residency Status Rural | 53 Participants | 28 Participants | — | — | — | 25 Participants |
| Residency Status Suburban | 83 Participants | 35 Participants | — | — | — | 48 Participants |
| Residency Status Urban | 111 Participants | 62 Participants | — | — | — | 49 Participants |
| Sex: Female, Male Female | 183 Participants | 84 Participants | 9 Participants | 5 Participants | 1 Participants | 84 Participants |
| Sex: Female, Male Male | 91 Participants | 41 Participants | 6 Participants | 2 Participants | 4 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 122 | 1 / 125 | 0 / 15 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 122 | 0 / 125 | 0 / 15 | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 1 / 122 | 0 / 125 | 0 / 15 | 0 / 7 | 0 / 7 |
Outcome results
Primary
Change From Baseline Systolic Blood Pressure (BP) at 6 Months
Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure
Time frame: Baseline and 6 months
Population: Primary Outcomes data was not collected on Phase 1 Stakeholders, Phase 2: TargEted MAnageMent Intervention (TEAM) - Peer Educators, or Phase 2: TargEted MAnageMent Intervention (TEAM) - Care Partners
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TargEted MAnageMent Intervention (TEAM) | Change From Baseline Systolic Blood Pressure (BP) at 6 Months | Baseline | 145.7 millimeters of mercury (mmHg) | Standard Deviation 21.5 |
| TargEted MAnageMent Intervention (TEAM) | Change From Baseline Systolic Blood Pressure (BP) at 6 Months | 6-months | 137.4 millimeters of mercury (mmHg) | Standard Deviation 18.1 |
| Enhanced Treatment as Usual (ETAU) | Change From Baseline Systolic Blood Pressure (BP) at 6 Months | Baseline | 141.9 millimeters of mercury (mmHg) | Standard Deviation 18.4 |
| Enhanced Treatment as Usual (ETAU) | Change From Baseline Systolic Blood Pressure (BP) at 6 Months | 6-months | 141.1 millimeters of mercury (mmHg) | Standard Deviation 21.9 |