Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT03924531

Collaborator

(none)

Enrollment

Location

Arms

19.9

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adherence is a major problem for the approximately one-third of Americans over the age of 20 who suffer from Hypertension (HTN). Hypertension can be controlled through medication adherence and lifestyle modifications (diet and exercise). However, nearly 50% of those with HTN report poor adherence to their antihypertensive medications, lifestyle changes, or both as primary reasons for failing to control their blood pressure. Currently, behavioral interventions are limited to providing education or reminding individuals to take better care of themselves by starting and adhering to proper diet and exercise program. Given the lack of adherence reported, education and reminders alone may not be sufficient to promote health behavior change. Interventions that appeal to individual's internal drive may be more effective, given that behavior adoption and maintenance are usually associated with intrinsic motivation and volition. Mindfulness practice is an intervention that shows promise in changing lifestyle behaviors. The purpose of this study is to investigate the use of UCLA's Mindful Awareness Program (UCLAMAP) on promoting self-management behaviors, specifically adherence to medication, diet, and exercise for those individuals with HTN. We will randomize 52 individuals with HTN who have difficulty with adherence to antihypertensive medications and lifestyle changes to the intervention group or the attention-control group. The intervention includes six sessions of the mindfulness training through UCLA's Mindful Awareness Research Center (MARC).

Condition or Disease	Intervention/Treatment	Phase
Health Behavior Modification Using Mindfulness	Behavioral: Mindful Awareness Program Behavioral: Health Promotion Program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Mar 31, 2019

Actual Study Completion Date :

Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindful Awareness Program The group that received mindfulness training.	Behavioral: Mindful Awareness Program 2-hour mindfulness training for 6 weeks. Other Names: Mindfulness training
Active Comparator: Health Promotion Program The group that received the health information.	Behavioral: Health Promotion Program Health Promotion Program

Arm

Intervention/Treatment

Experimental: Mindful Awareness Program

The group that received mindfulness training.

Behavioral: Mindful Awareness Program

2-hour mindfulness training for 6 weeks.

Other Names:

Mindfulness training

Active Comparator: Health Promotion Program

The group that received the health information.

Behavioral: Health Promotion Program

Health Promotion Program

Outcome Measures

Primary Outcome Measures

Diet [up to 12 weeks]
21 item questionnaire called Rapid Eating and Activity Assessment for Patients (REAP). Various questions related to food choices. The answer choices were rarely, sometimes, and often for each food questions.
Exercise [up to 12 weeks]
The instrument used was called the Brief Physical Assessment. The is a 6 item weekly questionnaire that asked the minutes the participants performed a particular exercise behavior.
Blood pressure medication adherence [up to 12 weeks]
The instrument used was called the Brief Medication Questionnaire (BMQ).The tool includes a 5-item Regimen Screen that asks patients how they took each medication in the past week, a 2-item Belief Screen that asks about drug effects and bothersome features, and a 2-item Recall Screen about potential difficulties remembering. We collected the number of missed medication days.

Secondary Outcome Measures

Blood pressure measurements [up to 12 weeks]
The participants were provided with blood pressure monitors to take home and log their blood pressure measurements daily. Blood pressure measurements were collected weekly. Systolic and diastolic blood pressure measurements will be accessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

over 21 years of age
able to understand and speak English
self-report of having difficulty with a healthy diet and engaging in regular physical activity.

Exclusion Criteria:

On chemotherapy for cancer treatment
Current substance abuse disorder (i.e., drugs, alcohol).
Current diagnoses of Post-traumatic stress disorders, severe anxiety, or severe depression.
On hemodialysis.
Pregnant. (Pregnant women may develop Preeclampsia, which is a pregnancy complication characterized by high blood pressure)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095

Sponsors and Collaborators

University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eunjoo An, PhD student, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT03924531

Other Study ID Numbers:

17-000411

First Posted:

Apr 23, 2019

Last Update Posted:

May 1, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eunjoo An, PhD student, University of California, Los Angeles

Study Results

No Results Posted as of May 1, 2019