Clinical trial NCT01770756: FSU Hypertension Self-Care Training Study
Official title: Improving the Willpower-based Self-care for Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
High blood pressure
Willpower
Self care
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 88
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effects of two forms of self-care training on overall health of adults with hypertension
timeFrame: 20 weeks from beginning of training sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: FSU College of Social Work
state: Florida
Study officials:
affiliation: Florida State University
name: Amy L Ai, PhD
role: PRINCIPAL_INVESTIGATOR
References: