FSU Hypertension Self-Care Training Study

June 29, 2022 updated by: Florida State University

Improving the Willpower-based Self-care for Hypertension

The purpose of this study is to compare the effectiveness of two forms of self-care training on the overall health of adults with hypertension.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The FSU College of Social Work and the Department of Psychology are seeking adults age 25 and older with a clinical diagnosis of hypertension for a randomized trial using willpower to manage high blood pressure. Voluntary participants will complete three phases: baseline, intervention, and post-treatment. Baseline phase includes a preliminary phone screening, fasting blood draw, physiological test (measuring heart rate variability, chest compression, etc.), and a psychosocial inventory. Intervention phase includes 8 weeks of once weekly trainings (approximately one hour long) to be held on a weekday evening. Participants will be randomly assigned to one of the two willpower groups and will be asked to rehearse the willpower method at least once daily for 30 minutes during these 8 weeks. Post-treatment phase includes two follow-up booster sessions (at week 12 and week 16) for refreshing willpower techniques, a follow-up fasting blood draw, a physiological test, and a psychosocial inventory.

Participation is completely voluntary and confidential. Volunteers completing each of the phases will be compensated $100 for their time. If someone is interested in participating, they should call our office at 850-645-0247 or email fsuwillpower@gmail.com.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • FSU College of Social Work

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of hypertension
  • Age 25 or older

Exclusion Criteria:

  • Pregnancy
  • Participation in other clinical trials or drug/behavioral treatment
  • Previously participated in any other clinical trials/training on health-related behavior (tai-chi, yoga, nutritional education, yoga class)
  • Kidney disease
  • Cancer/chemotherapy, advanced HIV/AIDS, severe liver disease
  • Severe ischemic heart disease (unstable angina, hospitalization for heart attack, coronary revascularization)
  • Congestive heart failure
  • Severe inflammatory/rheumatologic disorders (severe arthritis)
  • Severe mental health diagnosis such as schizophrenia or bi-polar disorder
  • Occurrence of any neurological disorders such as stroke or dementia
  • Addicted to any legal/illegal drugs or alcohol without at least 1 year of sobriety
  • Any infectious conditions such as pneumonia, traumatic wound, or surgery that may cause inflammation in the past 14 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Enhancing willpower using active skills
This group will use active tasks such as learning skills using hands to enhance willpower.
Behavioral: Self-Care Training
EXPERIMENTAL: Enhancing willpower using passive tasks
This group will use passive tasks such as taking still postures to enhance willpower.
Behavioral: Self-Care Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of two forms of self-care training on overall health of adults with hypertension
Time Frame: 20 weeks from beginning of training sessions
20 weeks from beginning of training sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Investigators

  • Principal Investigator: Amy L Ai, PhD, Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

April 11, 2018

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (ESTIMATE)

January 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSU-2012.8601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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