Hypertension
Conditions
Keywords
Blood Pressure, High
Brief summary
This is a one-year study. The study's primary outcome is successful improvement of the Our Whole Lives for Hypertension (OWL-H) online patient education platform, based upon participant use and focus group feedback, to deliver information on self-management of hypertension and other cardiac risk factors, and to encourage self-monitoring of blood pressure. Specific Aim 1 - To pilot test the OWL-H platform for 8 weeks with 26 patients with hypertension (2 groups of 13) to refine its utility for home self-monitoring (number of times patients record home blood pressure and input this data onto OWL-H and engagement of self-management (i.e. # of logins, # of mind body sessions completed, # of times modules accessed each day)). Hypothesis 1: Eighty percent of patients will log in and record their blood pressures. Specific Aim 2 - At the end of each group, hold a focus group to obtain information about: 1) the barriers and facilitators of using the OWL-H platform and using OWL-H to self-monitor blood pressure at home, 2) satisfaction with OWL-H, 3) how OWL-H helped with reduction of number of cardiac risk factors (e.g., smoking, eating habits, perceived stress, and amount of exercise and health-related quality of life).
Detailed description
This is a one-year pre post clinical study. The study's primary outcome is successful improvement of the Our Whole Lives for Hypertension (OWL-H) online patient education platform, based upon participant use and focus group feedback, to deliver information on self-management of hypertension and other cardiac risk factors, and to encourage self-monitoring of blood pressure. We piloted online OWL-H platform for 8 weeks with 26 patients with hypertension to refine its utility for home self-monitoring. We also held a focus group to obtain information about: 1) the barriers and facilitators of using the OWL-H platform and using OWL-H to self-monitor blood pressure at home, 2) satisfaction with OWL-H, 3) how OWL-H helped with reduction of number of cardiac risk factors
Interventions
BEHAVIORALOWL-Hypertension 8 Wk Trial
Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
University of Massachusetts, Worcester
Paula Gardiner
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There are 2 cohorts taking part in the same intervention at 2 separate times.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female subjects of all races and ethnicities who are English-speaking adults over the age of 18 and who have a current diagnosis of hypertension.. OWL in currently only available in English. * Subjects' physical and mental health status will be sufficient to be able to comprehend instructions and participate in the interventions. * Subjects must be able to access computer technology (cellular phone, desktop, laptop) and the internet to utilize the online OWL-H.
Exclusion criteria
* Serious underlying systemic or co-morbid disease, including psychotic or manic symptoms, which preclude physical or cognitive ability to participate in the intervention. The risk-benefit ratio of the interventions for these individuals may be potentially higher than acceptable. * Active substance abuse, given that individuals who have active substance abuse pose a higher risk both to themselves and other members of the groups. * Beginning new hypertension treatments in the past week or planning to begin new hypertension treatments in the next few weeks, or planning a major medical event in the next few weeks, which would interfere with accurately determining the effect of the intervention on impact in this study. * Subjects who are pregnant will be not included in this study given that the risk-benefit ratio of this intervention may be higher than acceptable for these individuals due to the potential onset of non-study related gestational diabetes and/or gestational hypertension. Determination of pregnancy status will be based upon subject self-report. * Subjects who are not willing to participate in the intervention or attend the group visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Knowledge Questionnaire | 8 Week | The Blood Pressure Knowledge Questionnaire (BPKQ) was used to assess the participants' level of knowledge regarding common characteristics and risk factors of hypertension. It consists of 8 items covering topics like common symptoms, White Coat Syndrome, and the amount of salt consumed by the average American, with a mix of multiple choice (6 items) and true/false questions (2 items). The correct items are totaled, with a range of 1-8, and higher scores indicating more hypertension knowledge. The information needed to answer each item correctly was covered in OWL-H's curriculum. |
| Hypertension Self-Care Profile Self-Efficacy Instrument | 8 weeks | The self-efficacy instrument of the Hypertension Self-care Profile (HTN-SCP-SE) used for this study consists of 20 items assessing the respondent's confidence on a scale of 1 (Not confident) to 4 (Very confident) to regularly engage in lifestyle habits that are recommended for patients with high blood pressure. It was developed and validated in 2014. The instrument results in a total confidence/self-efficacy score ranging from 20-80, with higher scores indicating higher levels of confidence in engaging in heart-healthy lifestyle habits. |
| Mediterranean Diet Questionnaire | 8 Weeks | The Mediterranean Diet Questionnaire (MDQ) consists of 14 yes-no items that assess participant's consumption of heart protective or harming foods. It was originally developed in Spain in 2004 to briefly assess adherence to a Mediterranean Diet and has been validated in multiple studies. Items assess the type of food eaten and whether the appropriate serving size is consumed, on a weekly basis. Yes responses are totaled, resulting in a score ranging from 0-14, with higher scores indicating a higher adherence to the Mediterranean Diet. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of Time Blood Pressure Self-Monitoring Occurred During One Week | 8 weeks | To assess blood pressure self-monitoring pre-post, we first asked Are you regularly (at least once per week) able to measure your blood pressure outside of your doctor appointments?. Those who said yes were then asked How often, in a regular week, do you measure your blood pressure outside of your doctor appointments? In their post-surveys, they were again asked to estimate their average weekly number of entries. Along with these self-report numbers, the OWL-H platform also keeps a log of every blood pressure entered by each participant across the 8 weeks. |
| Number of Time Blood Pressure Self-Monitoring on the OWL Platform Occurred Per Week | 8 Weeks | Actual mean weekly entries of blood pressure readings in the OWL-H platform across the 8 weeks. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from July-October of 2019 from Worcester, MA area adult primary care clinics, and either self-referred (via flyers and brochures placed around the clinics) or were referred by their primary care providers.They were then screened for eligibility, including a current diagnosis of hypertension in their EMR, and consented.
Participants by arm
| Arm | Count |
|---|---|
| OWL-Hypertension 8 Wk Trial Two groups of thirteen participants will use the Our Whole Lives - Hypertension eHealth online tool for 8 weeks each, with baseline, midline, and follow-up data collected to determine any change due to the intervention.
OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | OWL-Hypertension 8 Wk Trial |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 12.1 |
| Blood Pressure Knowledge Questionnaire | 5.58 Scores on a scale STANDARD_DEVIATION 1.44 |
| Blood Pressure Self-Monitoring (Self-Reported) | 2.8 Measurements/week STANDARD_DEVIATION 1.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Hypertension Self-Care Profile Self-Efficacy Instrument | 63.67 Scores on a scale STANDARD_DEVIATION 9.06 |
| Mediterranean Diet Questionnaire | 7.65 Scores on a scale STANDARD_DEVIATION 2.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Blood Pressure Knowledge Questionnaire
The Blood Pressure Knowledge Questionnaire (BPKQ) was used to assess the participants' level of knowledge regarding common characteristics and risk factors of hypertension. It consists of 8 items covering topics like common symptoms, White Coat Syndrome, and the amount of salt consumed by the average American, with a mix of multiple choice (6 items) and true/false questions (2 items). The correct items are totaled, with a range of 1-8, and higher scores indicating more hypertension knowledge. The information needed to answer each item correctly was covered in OWL-H's curriculum.
Time frame: 8 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OWL-Hypertension 8 Wk Trial | Blood Pressure Knowledge Questionnaire | 6.13 score on a scale | Standard Deviation 1.23 |
Primary
Hypertension Self-Care Profile Self-Efficacy Instrument
The self-efficacy instrument of the Hypertension Self-care Profile (HTN-SCP-SE) used for this study consists of 20 items assessing the respondent's confidence on a scale of 1 (Not confident) to 4 (Very confident) to regularly engage in lifestyle habits that are recommended for patients with high blood pressure. It was developed and validated in 2014. The instrument results in a total confidence/self-efficacy score ranging from 20-80, with higher scores indicating higher levels of confidence in engaging in heart-healthy lifestyle habits.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OWL-Hypertension 8 Wk Trial | Hypertension Self-Care Profile Self-Efficacy Instrument | 65.54 score on a scale | Standard Deviation 7.56 |
Primary
Mediterranean Diet Questionnaire
The Mediterranean Diet Questionnaire (MDQ) consists of 14 yes-no items that assess participant's consumption of heart protective or harming foods. It was originally developed in Spain in 2004 to briefly assess adherence to a Mediterranean Diet and has been validated in multiple studies. Items assess the type of food eaten and whether the appropriate serving size is consumed, on a weekly basis. Yes responses are totaled, resulting in a score ranging from 0-14, with higher scores indicating a higher adherence to the Mediterranean Diet.
Time frame: 8 Weeks
Population: One participant did not fully complete this questionnaire at baseline, resulting in 23 rather than 24 participants assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OWL-Hypertension 8 Wk Trial | Mediterranean Diet Questionnaire | 9 score on a scale | Standard Deviation 1.68 |
Secondary
Number of Time Blood Pressure Self-Monitoring on the OWL Platform Occurred Per Week
Actual mean weekly entries of blood pressure readings in the OWL-H platform across the 8 weeks.
Time frame: 8 Weeks
Population: One participant never entered a blood pressure reading in OWL-H.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OWL-Hypertension 8 Wk Trial | Number of Time Blood Pressure Self-Monitoring on the OWL Platform Occurred Per Week | 2.74 Measurements per week | Standard Deviation 2.02 |
Secondary
Numbers of Time Blood Pressure Self-Monitoring Occurred During One Week
To assess blood pressure self-monitoring pre-post, we first asked Are you regularly (at least once per week) able to measure your blood pressure outside of your doctor appointments?. Those who said yes were then asked How often, in a regular week, do you measure your blood pressure outside of your doctor appointments? In their post-surveys, they were again asked to estimate their average weekly number of entries. Along with these self-report numbers, the OWL-H platform also keeps a log of every blood pressure entered by each participant across the 8 weeks.
Time frame: 8 weeks
Population: One participant never entered a blood pressure reading in OWL-H.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OWL-Hypertension 8 Wk Trial | Numbers of Time Blood Pressure Self-Monitoring Occurred During One Week | 4.78 measurement per week | Standard Deviation 1.9 |