FSU Hypertension Self-Care Training Study

Florida State University

Status: Terminated

Conditions: Hypertension

Treatments: Behavioral: Self-Care Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01770756

FSU-2012.8601

Details and patient eligibility

About

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.

Full 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 [e-mail].

Enrollment: 88 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

88 participants in 2 patient groups

Enhancing willpower using active skills

Experimental group

Description:

This group will use active tasks such as learning skills using hands to enhance willpower.

Treatment:

Behavioral: Self-Care Training

Enhancing willpower using passive tasks

Experimental group

Description:

This group will use passive tasks such as taking still postures to enhance willpower.

Treatment:

Behavioral: Self-Care Training