HypertensionNCT01770756
FSU Hypertension Self-Care Training Study
A study testing Self-Care Training in people with Hypertension, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Self-Care Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 11 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of hypertension
- Age 25 or older
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
United States1 site
FSU College of Social Work
Tallahassee, Florida, 32306
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Self-Care Training
- Keywords
- Hypertension, High blood pressure, Willpower, Self care
- Medical subject headings
- Hypertension, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Care TrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Enhancing willpower using active skills | Experimental | This group will use active tasks such as learning skills using hands to enhance willpower. Receives: Behavioral: Self-Care Training |
| Enhancing willpower using passive tasks | Experimental | This group will use passive tasks such as taking still postures to enhance willpower. Receives: Behavioral: Self-Care Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of two forms of self-care training on overall health of adults with hypertension
Measured: 20 weeks from beginning of training sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionApr 2018
- Study completion11 Apr 2018
Why it stopped: IRB terminated study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy L Ai, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770756
- Sponsor's protocol ID
- FSU-2012.8601
- Status last verified
- Jul 2015
- First submitted
- 16 Jan 2013
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Willpower-based Self-care for Hypertension
- ClinicalTrials.gov ID
- NCT01770756
- Acronym / sponsor ID
- FSU-2012.8601
- Conditions
- Hypertension
- Keywords
- Hypertension, High blood pressure, Willpower, Self care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB terminated study
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhancing willpower using active skills | Experimental | Behavioral: Self-Care TrainingThis group will use active tasks such as learning skills using hands to enhance willpower. |
| Enhancing willpower using passive tasks | Experimental | Behavioral: Self-Care TrainingThis group will use passive tasks such as taking still postures to enhance willpower. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of hypertension
- Age 25 or older
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Care Training | Behavioural | Enhancing willpower using active skills, Enhancing willpower using passive tasks |
Primary outcome
Effects of two forms of self-care training on overall health of adults with hypertension
Time frame: 20 weeks from beginning of training sessions
Results and safety
The study was stopped early (reason given: IRB terminated study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy L Ai, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Care Training in people with Hypertension, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: IRB terminated study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.