HypertensionTriumphNCT01024933
Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)
A study testing Positive Affect/Self-Affirmation/Motivational Interviewing and Educational and Behavioral in people with Hypertension, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The primary aim of this study is to evaluate whether an intervention that combines positive affect and self-affirmation with motivational interviewing (TRIUMPH) improves blood pressure control compared to an educational/behavioral contract intervention at 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Positive Affect/Self-Affirmation/Motivational Interviewing and Educational and Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older.
- Must be receiving care within the Renaissance Health Network for at least one year.
- Must have uncontrolled HTN defined as an average SBP>140 mmHg or DBP>90 mmHg on at least two previous visits in the past year and be taking at least one antihypertensive medication.
- Must self-identify as Black, or African American.
- Must have patient's physician to participate in the study.
Who cannot join
- Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks).
- Participation in other clinical trials.
- Diagnosis of cognitive dysfunction or significant psychiatric comorbidity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lincoln Medical and Mental Health Center
The Bronx, New York, 10451
About this study
The primary aim of this study is to evaluate whether an intervention that combines positive affect and self-affirmation with motivational interviewing (TRIUMPH) improves blood pressure control compared to an educational/behavioral contract intervention at 12 months. We hypothesize that a greater proportion of participants in the experimental arm of TRIUMPH will have adequate blood pressure control as defined by Seventh Joint National Committee on Detection, Evaluation and Treatment of Hypertension (JNC-7.)
Read the detailed description
TRIUMPH is designed to build on the findings of our previous studies by combining positive affect and self affirmation with motivational interviewing in order to increase blood pressure control in community based practices that care for large numbers of hypertensive black patients. Patients in both the educational and behavioral contract control group and would receive a workbook, would make a behavioral contract, and a home blood pressure monitor. The positive affect/self-affirmation group would receive the same components as the control group. In addition the experimental group would receive a positive affect/self-affirmation induction and motivational interviewing.
Both the control group and the experimental group would be followed at 2 month intervals. The outcome blood pressure control in this group will be contrasted to the knowledge/behavioral contract group. We hypothesize that we can increase the percent of patients who have blood pressure control to 75%.
- Conditions
- Hypertension
- Being tested
- Positive Affect/Self-Affirmation/Motivational Interviewing, Educational and Behavioral
- Keywords
- Hypertension, High Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Affect/Self-Affirmation/Motivational InterviewingBehavioural
The PASA group-intervention will receive small gifts one week prior to their scheduled follow up. The PASA intervention involves reminding participants to think about their proud and positive moments. The motivational interviewing intervention includes assessing the patient's motivation and confidence; elicit barriers and concerns; summarize in a non-threatening manner the 'pros' and 'cons' of patient's concerns, thereby eliciting positive self-motivational statements about the behavior. Follow up will be every two months.
Educational and BehavioralBehavioural
The Education and Behavioral Contract (Control group)will receive an educational workbook and behavioral contract. In addition, each patient will receive a home blood pressure device for self-monitoring, and will be called every two months.
| Study group | Role | What they receive |
|---|---|---|
| Educational and Behavioral | Placebo comparator | The Education and Behavioral Contract (Control group) will receive an educational workbook and behavioral contract. Each patient will receive a home blood pressure device for self-monitoring, and will be called every two months. Receives: Behavioral: Educational and Behavioral |
| PASA group-intervention | Experimental | The PASA group (Positive Affect/Self-Affirmation/Motivational Interviewing) will receive a positive-affect and self-affirmation intervention with motivational interviewing.These patients will also receive an educational workbook and behavioral contract. This is the intervention. Receives: Behavioral: Positive Affect/Self-Affirmation/Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the blood pressure control.
Measured: 12 months
Secondary outcomes (1)
The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionApr 2014
- Study completionApr 2014
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Carla Boutin-Foster, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024933
- Sponsor's protocol ID
- Triumph
- Other IDs
- 1P60MD003421-01
- Acronym
- Triumph
- Status last verified
- Feb 2017
- First submitted
- 1 Dec 2009
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: there is no plan to share
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)
- ClinicalTrials.gov ID
- NCT01024933
- Acronym / sponsor ID
- Triumph / Triumph
- Conditions
- Hypertension
- Keywords
- Hypertension, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jan 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 Dec 2009 (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 primary aim of this study is to evaluate whether an intervention that combines positive affect and self-affirmation with motivational interviewing (TRIUMPH) improves blood pressure control compared to an educational/behavioral contract intervention at 12 months. We hypothesize that a greater proportion of participants in the experimental arm of TRIUMPH will have adequate blood pressure control as defined by Seventh Joint National Committee on Detection, Evaluation and Treatment of Hypertension (JNC-7.)
Detailed description
TRIUMPH is designed to build on the findings of our previous studies by combining positive affect and self affirmation with motivational interviewing in order to increase blood pressure control in community based practices that care for large numbers of hypertensive black patients. Patients in both the educational and behavioral contract control group and would receive a workbook, would make a behavioral contract, and a home blood pressure monitor. The positive affect/self-affirmation group would receive the same components as the control group. In addition the experimental group would receive a positive affect/self-affirmation induction and motivational interviewing.
Both the control group and the experimental group would be followed at 2 month intervals. The outcome blood pressure control in this group will be contrasted to the knowledge/behavioral contract group. We hypothesize that we can increase the percent of patients who have blood pressure control to 75%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational and Behavioral | Placebo comparator | Behavioral: Educational and BehavioralThe Education and Behavioral Contract (Control group) will receive an educational workbook and behavioral contract. Each patient will receive a home blood pressure device for self-monitoring, and will be called every two months. |
| PASA group-intervention | Experimental | Behavioral: Positive Affect/Self-Affirmation/Motivational InterviewingThe PASA group (Positive Affect/Self-Affirmation/Motivational Interviewing) will receive a positive-affect and self-affirmation intervention with motivational interviewing.These patients will also receive an educational workbook and behavioral contract. This is the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older.
- Must be receiving care within the Renaissance Health Network for at least one year.
- Must have uncontrolled HTN defined as an average SBP>140 mmHg or DBP>90 mmHg on at least two previous visits in the past year and be taking at least one antihypertensive medication.
- Must self-identify as Black, or African American.
- Must have patient's physician to participate in the study.
Key exclusion criteria (3 listed)
- Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks).
- Participation in other clinical trials.
- Diagnosis of cognitive dysfunction or significant psychiatric comorbidity.
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 |
|---|---|---|
| Positive Affect/Self-Affirmation/Motivational InterviewingThe PASA group-intervention will receive small gifts one week prior to their scheduled follow up. The PASA intervention involves reminding participants to think about their proud and positive moments. The motivational interviewing intervention includes assessing the patient's motivation and confidence; elicit barriers and concerns; summarize in a non-threatening manner the 'pros' and 'cons' of patient's concerns, thereby eliciting positive self-motivational statements about the behavior. Follow up will be every two months. | Behavioural | PASA group-intervention |
| Educational and BehavioralThe Education and Behavioral Contract (Control group)will receive an educational workbook and behavioral contract. In addition, each patient will receive a home blood pressure device for self-monitoring, and will be called every two months. | Behavioural | Educational and Behavioral |
Primary outcome
The primary outcome is the blood pressure control.
Time frame: 12 months
1 secondary outcome
The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No. there is no plan to share
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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.
Carla Boutin-Foster, MD principal investigator
Weill Medical College of Cornell 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 Positive Affect/Self-Affirmation/Motivational Interviewing and Educational and Behavioral in people with Hypertension, run by Weill Medical College of Cornell 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 23 Feb 2017. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome is the blood pressure control. (time frame: 12 months). 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 23 Feb 2017.