Hypertension
Conditions
Keywords
Hypertension, Behavior modification, Randomized controlled trial, Treatment effectiveness, Telemedicine, Prevention
Brief summary
The purpose of this study is to determine whether a stage-matched intervention (SMI) will lower BP and improve treatment adherence compared to usual care (UC) or a health education intervention (HEI) in veterans with uncontrolled BP. The study will also examine the effect of SMI on patient's health-related quality of life, satisfaction, acceptability and determine its cost-effectiveness.
Detailed description
We propose a randomized controlled trial to evaluate the effect of telephone-delivered interventions (SMI and HEI) to improve BP control. Veterans with uncontrolled hypertension (n=533) will be randomized equally to 3 groups: 1) The SMI will use the Transtheoretical model (TTM) as the unifying framework. Veterans will receive TTM stage-matched counseling for exercise, diet, and medications via monthly counseling sessions. A social worker (SW) will assess each participant's behavior and deliver the appropriate tailored SMI based on their stage of change, decisional balance, self-efficacy and the skills model questions. 2) The HEI group receives monthly telephone calls by a SW during which they will receive education about hypertension management. 3) The UC group participates in all the in-person visits but does not receive monthly calls. There will be an initial 6-month active intervention phase followed by a 6 month monitoring phase to assess sustainability. All participants will visit the VAMC's at baseline and at 3, 6, and 12 months. Outcomes of interest include BP; adherence (to diet, exercise and medications); quality of life; satisfaction; acceptability; cost and cost-effectiveness. Patients will be blinded to which of the intervention arms (SMI or HEI) they are in, SW's will be blinded to patient's BP and staff measuring outcomes will be blinded to study assignment. The study will be analyzed using longitudinal data analysis methods using an intention to treat strategy.
Interventions
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients receiving continuity of care in the outpatient clinics will be eligible. This will be operationalized as 2 visits in the previous year. * Adults (= 21 years) with hypertension, on antihypertensive medication for = 1 year, and who have current uncontrolled BP will be enrolled. Patients with CVD: * chronic stable angina * unstable angina * uncomplicated myocardial infarction * coronary artery bypass surgery * percutaneous coronary angioplasty * atherectomy or stent placement * chronic stable angina pectoris * stable Class I or Class II congestive heart failure * stroke * peripheral vascular disease will be entered into the study if the CVD event or diagnosis occurred = 6 months ago.
Exclusion criteria
Patients with limited life expectancy (\< 1 year) due to severe co-existing non-CVD disease such as: * terminal illnesses such as terminal cancer * CVD \< 6 months ago * Class III or IV CHF * severe psychiatric illness such as psychosis * manic depression * alcohol abuse (\> 21 drinks/week) * serious chronic conditions like AIDS * tuberculosis * lupus * and end-stage renal failure will be excluded. * Other exclusions include inability to understand English * Lack of a landline telephone * Unable to follow the study protocol * Recent major surgery (\< 3 months) * Patients who are temporarily in the area and plan to move in \< 1 year or will not be available for follow-up * Those unable to provide informed consent. * All patients excluded and reason for exclusion will be recorded. * Prior to recruitment, each patient will be informed about the study and informed consent obtained.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Control | 6 months | Blood pressure Control at 6 months |
| Systolic Blood Pressure | 6 months | Mean systolic Blood Pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Cardio Exercise Hours From Baseline to 6 Months | baseline and 6 months | — |
| Change in Morisky Score From Baseline to 6 Months | baseline and 6 months | Morkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4. A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent |
| Change in Proportion With BP Under Control From Baseline to 6 Months | 6 months | — |
| Exercise Stage of Change | 6 months | The stages of change were: precontemplation, or no plans to adhere in \<6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for \<6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions. |
| Medication Stage of Change | 6 months | The stages of change were: precontemplation, or no plans to adhere in \<6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for \<6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week. |
| Diet Stage of Change | 6 months | The stages of change were: precontemplation, or no plans to adhere in \<6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for \<6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week. |
| Change in Systolic Blood Pressure From Baseline to 6 Months | Baseline and 6 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stage-Matched Intervention (SMI) 6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model | 176 |
| Health Education Intervention (HEI) 6 monthly calls of nontailored counseling for diet, medication and exercise | 177 |
| Usual Care (UC) treatment as usual for hypertension | 180 |
| Total | 533 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 3 |
| Overall Study | Lost to Follow-up | 12 | 14 | 6 |
| Overall Study | Moved out of state | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 2 | 0 |
Baseline characteristics
| Characteristic | Stage-Matched Intervention (SMI) | Health Education Intervention (HEI) | Usual Care (UC) | Total |
|---|---|---|---|---|
| Aerobic exercise | 5.3 hours per week STANDARD_DEVIATION 8.1 | 4.5 hours per week STANDARD_DEVIATION 5.9 | 5.0 hours per week STANDARD_DEVIATION 6.7 | 4.9 hours per week STANDARD_DEVIATION 6.7 |
| Age, Continuous Age and Standard Deviation | 66.4 years STANDARD_DEVIATION 8.8 | 66.5 years STANDARD_DEVIATION 12.8 | 65.4 years STANDARD_DEVIATION 10.2 | 66.1 years STANDARD_DEVIATION 18.5 |
| Blood pressure control BP controlled | 75 participants | 72 participants | 80 participants | 227 participants |
| Blood pressure control BP not controlled | 101 participants | 105 participants | 100 participants | 306 participants |
| Body mass index | 30.5 kg/m^2 STANDARD_DEVIATION 5.2 | 31.2 kg/m^2 STANDARD_DEVIATION 5.8 | 30.0 kg/m^2 STANDARD_DEVIATION 4.8 | 30.5 kg/m^2 STANDARD_DEVIATION 5.3 |
| Campus Brooklyn campus | 80 participants | 81 participants | 83 participants | 244 participants |
| Campus Manhattan campus | 96 participants | 96 participants | 97 participants | 289 participants |
| Diabetes Mellitus Diabetes mellitus | 71 participants | 83 participants | 81 participants | 235 participants |
| Diabetes Mellitus No diabetes mellitus | 105 participants | 94 participants | 99 participants | 298 participants |
| Diastolic blood pressure | 75.5 mm Hg STANDARD_DEVIATION 9.3 | 76.1 mm Hg STANDARD_DEVIATION 11.6 | 75.0 mm Hg STANDARD_DEVIATION 11.1 | 75.5 mm Hg STANDARD_DEVIATION 11.6 |
| Diet stage of change Action or Maintenance | 69 participants | 67 participants | 70 participants | 206 participants |
| Diet stage of change Precontemplation, Contemplation or Preparation | 107 participants | 110 participants | 110 participants | 327 participants |
| Education High school graduate or below | 72 participants | 89 participants | 87 participants | 248 participants |
| Education Some college or higher | 104 participants | 88 participants | 93 participants | 285 participants |
| Employment status Employed | 29 participants | 41 participants | 41 participants | 111 participants |
| Employment status Not employed | 147 participants | 136 participants | 139 participants | 422 participants |
| Estimated glomerular filtration rate (EGFR) | 79.9 mL/min/1.73m^2 STANDARD_DEVIATION 25.5 | 83.2 mL/min/1.73m^2 STANDARD_DEVIATION 46.3 | 80.6 mL/min/1.73m^2 STANDARD_DEVIATION 28.4 | 81.3 mL/min/1.73m^2 STANDARD_DEVIATION 35.8 |
| Exercise Stage of Change Action or Maintenance | 125 participants | 110 participants | 108 participants | 343 participants |
| Exercise Stage of Change Precontemplation, Contemplation, or Preparation | 51 participants | 67 participants | 72 participants | 190 participants |
| History of revascularization History of revascularization | 27 participants | 28 participants | 31 participants | 86 participants |
| History of revascularization No history of revascularization | 149 participants | 149 participants | 149 participants | 447 participants |
| Hyperlipidemia Hyperlipidemia | 39 participants | 38 participants | 52 participants | 129 participants |
| Hyperlipidemia No hyperlipidemia | 137 participants | 139 participants | 128 participants | 404 participants |
| Ischemic Heart Disease (IHD) History of IHD | 23 participants | 22 participants | 23 participants | 68 participants |
| Ischemic Heart Disease (IHD) No history of IHD | 153 participants | 155 participants | 157 participants | 465 participants |
| Marital status Married | 59 participants | 67 participants | 70 participants | 196 participants |
| Marital status Not Married | 117 participants | 110 participants | 110 participants | 337 participants |
| Medication adherence by Morisky scale | 3.4 units on a scale STANDARD_DEVIATION 0.93 | 3.2 units on a scale STANDARD_DEVIATION 0.67 | 3.3 units on a scale STANDARD_DEVIATION 0.94 | 3.3 units on a scale STANDARD_DEVIATION 0.88 |
| Medication Stage of Change Action or Maintenance | 164 participants | 170 participants | 166 participants | 500 participants |
| Medication Stage of Change Precontemplation, Contemplation or Preparation | 12 participants | 7 participants | 14 participants | 33 participants |
| Number of antihypertensive medications | 2.7 medications STANDARD_DEVIATION 1.5 | 2.8 medications STANDARD_DEVIATION 1.3 | 2.7 medications STANDARD_DEVIATION 1.3 | 2.7 medications STANDARD_DEVIATION 1.4 |
| Race/Ethnicity, Customized Black (non-Hispanic) | 65 participants | 77 participants | 70 participants | 212 participants |
| Race/Ethnicity, Customized Hispanic | 24 participants | 29 participants | 29 participants | 82 participants |
| Race/Ethnicity, Customized Other | 6 participants | 11 participants | 10 participants | 27 participants |
| Race/Ethnicity, Customized White (non-Hispanic) | 81 participants | 60 participants | 71 participants | 212 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 174 Participants | 176 Participants | 176 Participants | 526 Participants |
| Smoking Current non-smoker | 141 participants | 145 participants | 148 participants | 434 participants |
| Smoking Current smoker | 35 participants | 32 participants | 32 participants | 99 participants |
| Systolic Blood Pressure, mm Mg | 136.0 mm Hg STANDARD_DEVIATION 11.8 | 137.2 mm Hg STANDARD_DEVIATION 17.7 | 137.0 mm Hg STANDARD_DEVIATION 12.9 | 136.7 mm Hg STANDARD_DEVIATION 15.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 176 | 7 / 177 | 9 / 180 |
| serious Total, serious adverse events | 3 / 176 | 1 / 177 | 3 / 180 |
Outcome results
Primary
Blood Pressure Control
Blood pressure Control at 6 months
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage-matched Intervention (SMI) | Blood Pressure Control | BP controlled | 0.646 proportion of participants |
| Stage-matched Intervention (SMI) | Blood Pressure Control | BP not controlled | 0.354 proportion of participants |
| Health Education Intervention (HEI) | Blood Pressure Control | BP controlled | 0.543 proportion of participants |
| Health Education Intervention (HEI) | Blood Pressure Control | BP not controlled | 0.457 proportion of participants |
| Usual Care (UC) | Blood Pressure Control | BP controlled | 0.458 proportion of participants |
| Usual Care (UC) | Blood Pressure Control | BP not controlled | 0.542 proportion of participants |
Comparison: The study was an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. We expected that 54% of patients on BP-lowering therapy would be properly controlled with HEI and 43% with UC, whereas we expected SMI to increase this to 69% control in 6 months. BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), ie, 1.25% for each of the 4 comparisons.p-value: 0.001Wilcoxon (Mann-Whitney)
p-value: 0.108Wilcoxon (Mann-Whitney)
Primary
Systolic Blood Pressure
Mean systolic Blood Pressure
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage-matched Intervention (SMI) | Systolic Blood Pressure | 131.2 mm Hg |
| Health Education Intervention (HEI) | Systolic Blood Pressure | 131.8 mm Hg |
| Usual Care (UC) | Systolic Blood Pressure | 134.7 mm Hg |
Comparison: The study was designed as an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. The study was not powered to test comparisons between the 2 active intervention arms.p-value: 0.009Wilcoxon (Mann-Whitney)
p-value: 0.047Wilcoxon (Mann-Whitney)
Secondary
Change in Morisky Score From Baseline to 6 Months
Morkisy medication adherence self-report questionnaire, a 4-item questionnaire scored from 0-4. A score of 4 is considered most adherent, and scores of less than 4 are defined as nonadherent
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage-matched Intervention (SMI) | Change in Morisky Score From Baseline to 6 Months | 0.25 units on a scale |
| Health Education Intervention (HEI) | Change in Morisky Score From Baseline to 6 Months | 0.25 units on a scale |
| Usual Care (UC) | Change in Morisky Score From Baseline to 6 Months | 0.14 units on a scale |
p-value: 0.306Wilcoxon (Mann-Whitney)
p-value: 0.205Wilcoxon (Mann-Whitney)
Secondary
Change in Number of Cardio Exercise Hours From Baseline to 6 Months
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage-matched Intervention (SMI) | Change in Number of Cardio Exercise Hours From Baseline to 6 Months | -0.29 hours |
| Health Education Intervention (HEI) | Change in Number of Cardio Exercise Hours From Baseline to 6 Months | 0.53 hours |
| Usual Care (UC) | Change in Number of Cardio Exercise Hours From Baseline to 6 Months | -0.43 hours |
p-value: 0.88Wilcoxon (Mann-Whitney)
p-value: 0.318Wilcoxon (Mann-Whitney)
Secondary
Change in Proportion With BP Under Control From Baseline to 6 Months
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage-matched Intervention (SMI) | Change in Proportion With BP Under Control From Baseline to 6 Months | .197 Proportion of participants |
| Health Education Intervention (HEI) | Change in Proportion With BP Under Control From Baseline to 6 Months | .118 Proportion of participants |
| Usual Care (UC) | Change in Proportion With BP Under Control From Baseline to 6 Months | .019 Proportion of participants |
p-value: <0.000003McNemar
p-value: 0.012McNemar
p-value: 0.89McNemar
Secondary
Change in Systolic Blood Pressure From Baseline to 6 Months
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Stage-matched Intervention (SMI) | Change in Systolic Blood Pressure From Baseline to 6 Months | -4.7 mm Hg |
| Health Education Intervention (HEI) | Change in Systolic Blood Pressure From Baseline to 6 Months | -5.4 mm Hg |
| Usual Care (UC) | Change in Systolic Blood Pressure From Baseline to 6 Months | -2.7 mm Hg |
p-value: <0.009Wilcoxon (Mann-Whitney)
p-value: 0.008Wilcoxon (Mann-Whitney)
p-value: 0.9Wilcoxon (Mann-Whitney)
Secondary
Diet Stage of Change
The stages of change were: precontemplation, or no plans to adhere in \<6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for \<6 months; and maintenance, or adherence for ≥ 6 months. Patients were considered adherent to diet if they reported eating the appropriate diet for hypertension (low in salt and fat with fruits, vegetables, and low-or non-fat dairy products) at least 6 days per week.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage-matched Intervention (SMI) | Diet Stage of Change | Action or Maintenance | 87 participants |
| Stage-matched Intervention (SMI) | Diet Stage of Change | Precontemplation, Contemplation or Preparation | 69 participants |
| Health Education Intervention (HEI) | Diet Stage of Change | Action or Maintenance | 73 participants |
| Health Education Intervention (HEI) | Diet Stage of Change | Precontemplation, Contemplation or Preparation | 86 participants |
| Usual Care (UC) | Diet Stage of Change | Action or Maintenance | 73 participants |
| Usual Care (UC) | Diet Stage of Change | Precontemplation, Contemplation or Preparation | 97 participants |
p-value: 0.011Chi-squared
p-value: 0.638Chi-squared
Secondary
Exercise Stage of Change
The stages of change were: precontemplation, or no plans to adhere in \<6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for \<6 months; and maintenance, or adherence for ≥ 6 months. Exercise adherence was defined as self-reported aerobic exercise for at least 3 days per week for at least 20 minutes each time. We used the lower threshold for exercise adherence due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage-matched Intervention (SMI) | Exercise Stage of Change | Action or Maintenance | 128 participants |
| Stage-matched Intervention (SMI) | Exercise Stage of Change | Precontemplation, Contemplation or Preparation | 28 participants |
| Health Education Intervention (HEI) | Exercise Stage of Change | Action or Maintenance | 124 participants |
| Health Education Intervention (HEI) | Exercise Stage of Change | Precontemplation, Contemplation or Preparation | 35 participants |
| Usual Care (UC) | Exercise Stage of Change | Action or Maintenance | 126 participants |
| Usual Care (UC) | Exercise Stage of Change | Precontemplation, Contemplation or Preparation | 44 participants |
p-value: 0.012Chi-squared
p-value: 0.333Chi-squared
Secondary
Medication Stage of Change
The stages of change were: precontemplation, or no plans to adhere in \<6 months; contemplation, or plans to adhere in 1-6 months; preparation, or plans to adhere within 1 month; action, or adherence for \<6 months; and maintenance, or adherence for ≥ 6 months. Medication adherence was defined as self-report of taking BP medications as prescribed for at least 6 days per week.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage-matched Intervention (SMI) | Medication Stage of Change | Action or Maintenance | 148 participants |
| Stage-matched Intervention (SMI) | Medication Stage of Change | Precontemplation, Contemplation or Preparation | 8 participants |
| Health Education Intervention (HEI) | Medication Stage of Change | Action or Maintenance | 156 participants |
| Health Education Intervention (HEI) | Medication Stage of Change | Precontemplation, Contemplation or Preparation | 3 participants |
| Usual Care (UC) | Medication Stage of Change | Action or Maintenance | 163 participants |
| Usual Care (UC) | Medication Stage of Change | Precontemplation, Contemplation or Preparation | 7 participants |
p-value: 0.581Chi-squared
p-value: 0.502Chi-squared