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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage-matched intervention (SMI) | Experimental | Stage-matched intervention (SMI) |
|
| Health Education Intervention (HEI) | Active Comparator | Health Education Intervention (HEI) |
|
| Usual Care (UC) | No Intervention | Usual Care (UC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMI | Behavioral | Stage-matched intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Control | Blood pressure Control at 6 months | 6 months |
| Systolic Blood Pressure | Mean systolic Blood Pressure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Proportion With BP Under Control From Baseline to 6 Months | 6 months | |
| Change in Systolic Blood Pressure From Baseline to 6 Months | Baseline and 6 months | |
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Inclusion Criteria:
Patients with CVD:
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:
will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Sundar Natarajan, MD MSc | VA New York Harbor Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA New York Harbor Health Care System | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18565801 | Result | Ulmer M, Robinaugh D, Friedberg JP, Lipsitz SR, Natarajan S. Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention. Contemp Clin Trials. 2008 Sep;29(5):705-10. doi: 10.1016/j.cct.2008.04.005. Epub 2008 May 6. | |
| 19525084 | Result | Friedberg JP, Lipsitz SR, Natarajan S. Challenges and recommendations for blinding in behavioral interventions illustrated using a case study of a behavioral intervention to lower blood pressure. Patient Educ Couns. 2010 Jan;78(1):5-11. doi: 10.1016/j.pec.2009.04.009. Epub 2009 Jun 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage-matched Intervention (SM) | 6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model |
| FG001 | Health Education Intervention (HEI) | 6 monthly phone calls of non-tailored counseling for diet, medication and exercise |
| FG002 | Usual Care (UC) | treatment as usual with no additional counseling |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage-Matched Intervention (SMI) | 6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model |
| BG001 | Health Education Intervention (HEI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure Control | Blood pressure Control at 6 months | Posted | Number | proportion of participants | 6 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage-matched Intervention (SMI) | 6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart attack | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sundar Natarajan, MD, Staff Physician | Department of Veterans Affairs | 212-686-7500 | 3287 | Sundar.Natarajan@va.gov |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| HEI |
| Behavioral |
Health Education Intervention |
|
| UC | Behavioral | Usual Care |
|
| SMI | Behavioral | Stage-matched intervention |
|
| HEI | Behavioral | Health Education Intervention |
|
| UC | Behavioral | Usual Care |
|
| 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 | 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 | baseline and 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 25403606 | Result | Friedberg JP, Rodriguez MA, Watsula ME, Lin I, Wylie-Rosett J, Allegrante JP, Lipsitz SR, Natarajan S. Effectiveness of a tailored behavioral intervention to improve hypertension control: primary outcomes of a randomized controlled trial. Hypertension. 2015 Feb;65(2):440-6. doi: 10.1161/HYPERTENSIONAHA.114.03483. Epub 2014 Nov 17. |
| 33979183 | Derived | Rodriguez MA, Wang B, Hyoung S, Friedberg J, Wylie-Rosett J, Fang Y, Allegrante JP, Lipsitz SR, Natarajan S. Sustained Benefit of Alternate Behavioral Interventions to Improve Hypertension Control: A Randomized Clinical Trial. Hypertension. 2021 Jun;77(6):1867-1876. doi: 10.1161/HYPERTENSIONAHA.120.15192. Epub 2021 May 12. |
| Lost to Follow-up |
|
| Moved out of state |
|
6 monthly calls of nontailored counseling for diet, medication and exercise
| BG002 | Usual Care (UC) | treatment as usual for hypertension |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Marital status | Number | participants |
|
| Education | Number | participants |
|
| Employment status | Number | participants |
|
| Campus | Number | participants |
|
| Smoking | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Blood pressure control | Controlled BP was defined as systolic BP (SBP) less than130 mm Hg or Diastolic BP (DBP) less than 80 mm Hg in diabetes mellitus or chronic kidney disease, or SBP less than140 mm Hg or DBP less than 90 mm Hg in all others as per the BP guidelines at the time of the study. | Number | participants |
|
| Diabetes Mellitus | From chart review | Number | participants |
|
| Ischemic Heart Disease (IHD) | self-reported | Number | participants |
|
| History of revascularization | self-reported | Number | participants |
|
| Hyperlipidemia | Hyperlipidemia was defined as LDL cholesterol of greater than or equal to 100 mg/dL from laboratory results | Number | participants |
|
| Estimated glomerular filtration rate (EGFR) | Mean | Standard Deviation | mL/min/1.73m^2 |
|
| Systolic Blood Pressure, mm Mg | Mean | Standard Deviation | mm Hg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| Aerobic exercise | Mean | Standard Deviation | hours per week |
|
| Medication adherence by Morisky scale | Morisky medication-taking scale is a 4-item questionnaire scored from 0-4, with 4 being most adherent and less than 4 being considered nonadherent | Mean | Standard Deviation | units on a scale |
|
| Number of antihypertensive medications | Mean | Standard Deviation | medications |
|
| 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. | Number | participants |
|
| 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 adherence19, 20 due to our patient population with multiple comorbidities, consistent with Federal guidelines for older adults with chronic conditions. | Number | participants |
|
| 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. | Number | participants |
|
|
|
|
| Primary | Systolic Blood Pressure | Mean systolic Blood Pressure | Posted | Mean | 95% Confidence Interval | mm Hg | 6 months |
|
|
|
|
| Secondary | Change in Proportion With BP Under Control From Baseline to 6 Months | Posted | Number | Proportion of participants | 6 months |
|
|
|
|
| Secondary | Change in Systolic Blood Pressure From Baseline to 6 Months | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline and 6 months |
|
|
|
|
| Secondary | Change in Number of Cardio Exercise Hours From Baseline to 6 Months | Posted | Mean | 95% Confidence Interval | hours | baseline and 6 months |
|
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and 6 months |
|
|
|
|
| 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. | Posted | Number | participants | 6 months |
|
|
|
|
| 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. | Posted | Number | participants | 6 months |
|
|
|
|
| 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. | Posted | Number | participants | 6 months |
|
|
|
|
| 3 |
| 176 |
| 14 |
| 176 |
| EG001 | Health Education Intervention (HEI) | 6 monthly phone calls of nontailored counseling for diet, medication and exercise | 1 | 177 | 7 | 177 |
| EG002 | Usual Care (UC) | treatment as usual for hypertension | 3 | 180 | 9 | 180 |
| Stroke | Vascular disorders | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
| broken bones | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| torn ligament | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hypertensive emergency | Cardiac disorders | Non-systematic Assessment |
|
| Coronary artery bypass graft | Surgical and medical procedures | Non-systematic Assessment |
|
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| Wilcoxon (Mann-Whitney) | 0.047 | BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC | 2-Sided | No | Superiority or Other |
| McNemar |
| 0.012 |
Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests). |
| 2-Sided |
| No |
| Superiority or Other |
| McNemar | 0.89 | Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests). | 2-Sided | No | Superiority or Other |
| 0.008 |
Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately). |
| 2-Sided |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.9 | Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately). | 2-Sided | No | Superiority or Other |
| 0.318 |
Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately). |
| 2-Sided |
| No |
| Superiority or Other |
| 0.205 |
| 2-Sided |
| No |
| Superiority or Other |
|
| 0.638 |
Since we are performing 3 tests, we will adjust the type I error to 0.017 |
| 2-Sided |
| No |
| Superiority or Other |
|
| 0.333 |
Since we are performing 3 tests, we will adjust the type I error to 0.017 |
| 2-Sided |
| No |
| Superiority or Other |
|
| 0.502 |
Since we are performing 3 tests, we will adjust the type I error to 0.017 |
| 2-Sided |
| No |
| Superiority or Other |