Interactive Web Program and Health Coaching for Prehypertensive Adults

Blood Pressure Clinical Trial

— Prehype  

Official title:

Interactive Web Program and Health Coaching for Prehypertensive Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02637063
• Other study ID #: R44HL095229
• Secondary ID: R44HL095229
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 9, 2015
• Last updated: December 17, 2015
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Oregon Center for Applied Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This project will develop and evaluate an interactive blood pressure self-management program for adults with prehypertension. The program will target blood pressure self-monitoring and the five proven lifestyle modifications recommended by JNC-7: weight reduction, the Dietary Approaches to Stop Hypertension (DASH) diet, sodium reduction, physical activity, and alcohol consumption.

The multi-modal program uses a combination of brief motivational health coaching, periodic engagement emails, and a robust interactive website to motivate people to take charge of their blood pressure management before they require medication. All program components were designed to conform to the underlying principles of motivational interviewing. Key program components include the use of email and Web-based social networking, personal stories, and a brief motivational coaching session to engage participants and encourage intrinsically motivated behavior changes. Self-assessment and tracking tools are combined with educational content to help participants align their daily lifestyle choices with their personal goals.

The Phase I prototype program promoted moderate physical activity and eating fruits and vegetables as part of the DASH diet. Results from the within-group (n = 39) evaluation showed moderate-to-large effect sizes for pre-to-post change in motivation, preparation behavior, self-efficacy, attitudes, and knowledge, and a small significant increase in physical activity. Participants gave the online program high ratings on satisfaction and usability, and reported improvements in confidence, readiness, clarity, change strategies, and interest in visiting the Website as a result of the coaching session.

The fully developed Phase II product will be evaluated in a large randomized trial (N = 450) with a 3-month intensive intervention, a 3-month maintenance intervention, and a 3-month follow-up period. The Phase II trial is expected to show reductions in blood pressure and improvements in JNC-recommended health behaviors. These changes in the outcome measures are expected to be mediated by changes in knowledge, attitudes, self-efficacy, behavioral intention, motivation, and patient activation.

Description:

Approximately a third (31%) of adult Americans are prehypertensive (SBP 120-139 and/or DBP 80-89). Health care providers struggle to provide effective support for blood-pressure-lowering behavior changes, while patients continue to progress to full hypertension and the use of antihypertensive medications. Insurers and providers with access to electronic medical records, claims, and other medical data are in a unique position to identify prehypertensive adults and target them with a blood pressure self-management program. Preventing or delaying hypertension should reduce mid-term costs of antihypertensive medications and, more importantly, long-term costs of care for heart disease and stroke.

This project will develop and evaluate an interactive blood pressure self-management program for adults with prehypertension. The program will target blood pressure self-monitoring and the five proven lifestyle modifications recommended by JNC-7: weight reduction, the Dietary Approaches to Stop Hypertension (DASH) diet, sodium reduction, physical activity, and alcohol consumption.

The multi-modal program uses a combination of brief motivational health coaching, periodic engagement emails, and a robust interactive website to motivate people to take charge of their blood pressure management before they require medication. All program components were designed to conform to the underlying principles of motivational interviewing. Key program components include the use of email and Web-based social networking, personal stories, and a brief motivational coaching session to engage participants and encourage intrinsically motivated behavior changes. Self-assessment and tracking tools are combined with educational content to help participants align their daily lifestyle choices with their personal goals.

The Phase I prototype program promoted moderate physical activity and eating fruits and vegetables as part of the DASH diet. Results from the within-group (n = 39) evaluation showed moderate-to-large effect sizes for pre-to-post change in motivation, preparation behavior, self-efficacy, attitudes, and knowledge, and a small significant increase in physical activity. Participants gave the online program high ratings on satisfaction and usability, and reported improvements in confidence, readiness, clarity, change strategies, and interest in visiting the Website as a result of the coaching session.

The fully developed Phase II product will be evaluated in a large randomized trial (N = 450) with a 3-month intensive intervention, a 3-month maintenance intervention, and a 3-month follow-up period. The Phase II trial is expected to show reductions in blood pressure and improvements in JNC-recommended health behaviors. These changes in the outcome measures are expected to be mediated by changes in knowledge, attitudes, self-efficacy, behavioral intention, motivation, and patient activation.

The Phase II product will be marketed to large, integrated health benefits providers with both insurance and wellness products, like the investigators Phase II evaluation partner Aetna, and to integrated health service delivery systems, like the investigators Phase I and II evaluation partner, Providence Health.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Blood pressure in the JNC-7-defined prehypertension range (SBP 120-139 and/or DBP 80-89)

• Must be at least 18 years old

• Must be employed at least part time

• Must have access to the internet through a WIFI connection in a place where subject was willing to take BP and weight measurements

• Must be the only participant per household in the study

Exclusion Criteria

• Female subjects must not be pregnant or planning to get pregnant over the course of study

• Must not have experienced a stroke, heart attack, or heart disease diagnosis in the prior six months

• Must not be taking antihypertensive medications for any reason

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label

Related Conditions & MeSH terms

• Blood Pressure
• Weight

Intervention

Behavioral:
• BlipHub only

• BlipHub + coaching

Other:
• Usual care

Locations

Country	Name	City	State
United States	ORCAS	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Center for Applied Science, Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in systolic blood pressure		Baseline, 4 weeks, 12 weeks, 24 weeks	No
Primary	Change from baseline in diastolic blood pressure		Baseline, 4 weeks, 12 weeks, 24 weeks	No
Primary	Change from baseline in body weight		Baseline, 4 weeks, 12 weeks, 24 weeks	No
Primary	Change from baseline in the Weight Control Strategies Scale		Baseline, 4 weeks, 12 weeks, 24 weeks	No
Primary	Change from baseline in self-reported physical activity using the International Physical Activity Questionnaire		Baseline, 4 weeks, 12 weeks, 24 weeks	No
Primary	Change from baseline in heart-healthy dietary intake (number of fruit/vegetable servings, white meat servings, low-fat dairy servings)		Baseline, 4 weeks, 12 weeks, 24 weeks	No
Primary	Change from baseline in heart-unhealthy dietary intake (self-reported number of fat servings, red meat servings, dairy fat servings)		Baseline, 4 weeks, 12 weeks, 24 weeks	No
Secondary	Change from baseline in self-reported lifestyle change preparation behavior questionnaire		Baseline, 4 weeks, 12 weeks, 24 weeks	No
Secondary	Change from baseline in self-reported self-efficacy for lifestyle behavior questionnaire		Baseline, 4 weeks, 12 weeks, 24 weeks	No
Secondary	Change from baseline in workplace productivity based on the Workplace Outcomes Suite		Baseline, 4 weeks, 12 weeks, 24 weeks	No