FSU Hypertension Self-Care Training Study
Primary Purpose
Hypertension
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Care Training
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, High blood pressure, Willpower, Self care
Eligibility Criteria
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
Sites / Locations
- FSU College of Social Work
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Enhancing willpower using active skills
Enhancing willpower using passive tasks
Arm Description
This group will use active tasks such as learning skills using hands to enhance willpower.
This group will use passive tasks such as taking still postures to enhance willpower.
Outcomes
Primary Outcome Measures
Effects of two forms of self-care training on overall health of adults with hypertension
Secondary Outcome Measures
Full Information
NCT ID
NCT01770756
First Posted
January 16, 2013
Last Updated
June 29, 2022
Sponsor
Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT01770756
Brief Title
FSU Hypertension Self-Care Training Study
Official Title
Improving the Willpower-based Self-care for Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
IRB terminated study
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, High blood pressure, Willpower, Self care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhancing willpower using active skills
Arm Type
Experimental
Arm Description
This group will use active tasks such as learning skills using hands to enhance willpower.
Arm Title
Enhancing willpower using passive tasks
Arm Type
Experimental
Arm Description
This group will use passive tasks such as taking still postures to enhance willpower.
Intervention Type
Behavioral
Intervention Name(s)
Self-Care Training
Primary Outcome Measure Information:
Title
Effects of two forms of self-care training on overall health of adults with hypertension
Time Frame
20 weeks from beginning of training sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy L Ai, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
FSU College of Social Work
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FSU Hypertension Self-Care Training Study
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