NCT01770756

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2018

Completed
Last Updated

July 5, 2022

Status Verified

July 1, 2015

Enrollment Period

5.7 years

First QC Date

January 16, 2013

Last Update Submit

June 29, 2022

Conditions

Keywords

HypertensionHigh blood pressureWillpowerSelf care

Outcome Measures

Primary Outcomes (1)

  • Effects of two forms of self-care training on overall health of adults with hypertension

    20 weeks from beginning of training sessions

Study Arms (2)

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

Enhancing willpower using active skillsEnhancing willpower using passive tasks

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of hypertension
  • Age 25 or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FSU College of Social Work

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

HypertensionSelf-Control

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSocial BehaviorBehavior

Study Officials

  • Amy L Ai, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

August 1, 2012

Primary Completion

April 1, 2018

Study Completion

April 11, 2018

Last Updated

July 5, 2022

Record last verified: 2015-07

Locations