FSU Hypertension Self-Care Training Study | NCT01770756

Studies
FSU Hypertension Self-Care Training Study

NCT01770756

Sponsor

Florida State University

Status

Terminated

Last Update Posted

Jul 5, 2022Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Self-Care Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IRB terminated study

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 11, 2018Actual

First Submitted Date

Jan 16, 2013

First Submission Date that Met QC Criteria

Jan 16, 2013

First Posted Date

Jan 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2022

Last Update Posted Date

Jul 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enhancing willpower using active skills	Experimental	This group will use active tasks such as learning skills using hands to enhance willpower.	Behavioral: Self-Care Training
Enhancing willpower using passive tasks	Experimental	This group will use passive tasks such as taking still postures to enhance willpower.	Behavioral: Self-Care Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self-Care Training	Behavioral		Enhancing willpower using active skills Enhancing willpower using passive tasks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of two forms of self-care training on overall health of adults with hypertension		20 weeks from beginning of training sessions

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy L Ai, PhD	Florida State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FSU College of Social Work		Tallahassee	Florida	32306	United States

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D000068356	Self-Control

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012919	Social Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided