FSU Hypertension Self-Care Training Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Florida State University
Sponsor:
Information provided by (Responsible Party):
Florida State University
ClinicalTrials.gov Identifier:
NCT01770756
First received: January 16, 2013
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Self-Care Training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving the Willpower-based Self-care for Hypertension

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Effects of two forms of self-care training on overall health of adults with hypertension [ Time Frame: 20 weeks from beginning of training sessions ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770756

Contacts
Contact: Amy L Ai, PhD 850-645-0247 fsuwillpower@gmail.com
Contact: Jaime E Ayers, BSW, BSFCS 850-645-0247 fsuwillpower@gmail.com

Locations
United States, Florida
FSU College of Social Work Recruiting
Tallahassee, Florida, United States, 32306
Contact: Amy L Ai, PhD    850-645-0247    fsuwillpower@gmail.com   
Principal Investigator: Amy L Ai, PhD         
Sponsors and Collaborators
Florida State University
Investigators
Principal Investigator: Amy L Ai, PhD Florida State University
  More Information

No publications provided

Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT01770756     History of Changes
Other Study ID Numbers: FSU-2012.8601
Study First Received: January 16, 2013
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Florida State University:
Hypertension
High blood pressure
Willpower
Self care

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014