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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

January 16, 2013
July 11, 2014
August 2012
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01770756 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
FSU Hypertension Self-Care Training Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
Behavioral: Self-Care Training
  • Experimental: Enhancing willpower using active skills
    This group will use active tasks such as learning skills using hands to enhance willpower.
    Intervention: Behavioral: Self-Care Training
  • Experimental: Enhancing willpower using passive tasks
    This group will use passive tasks such as taking still postures to enhance willpower.
    Intervention: Behavioral: Self-Care Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
25 Years and older
No
Contact: Amy L Ai, PhD 850-645-0247 fsuwillpower@gmail.com
Contact: Jaime E Ayers, BSW, BSFCS 850-645-0247 fsuwillpower@gmail.com
United States
 
NCT01770756
FSU-2012.8601
No
Florida State University
Florida State University
Not Provided
Principal Investigator: Amy L Ai, PhD Florida State University
Florida State University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP