Essential HypertensionNCT00208104
Motivational Interviewing
A study testing Motivational Interviewing in people with Essential Hypertension, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this project is to study ways to make it more likely that patients will take their blood pressure medicine as recommended by their doctors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Sep 2008
- 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
- The target population consisted of hypertensive African American patients who fulfilled the following eligibility criteria:
- Self-identification as African American
- Age 18 years or older
- Diagnosis of hypertension utilizing ICD-9 codes 401-401.9 (the code for essential hypertension)
- Taking at least one antihypertensive medication
- Uncontrolled hypertension of a clinic blood pressure reading >140/90 mm Hg or 130/80 mm Hg (for those with kidney disease or diabetes) on two successive clinic visits prior to screening (defined per JNC VI criteria)
- Fluent in English language
Who cannot join
- Participants were excluded if they:
- Had a diagnosis of cognitive impairment or serious medical condition as determined by their primary physician
- Were unable to give informed consent
- Refused to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Motivational Interviewing in Hypertensive African Americans
The purpose of this project is to study ways to make it more likely that patients will take their blood pressure medicine as recommended by their doctors.
Read the detailed description
The objective of this randomized control trial is to evaluate, among 190 African-American patients with poorly controlled hypertension followed in a community-based primary care practice, whether motivational interviewing is more effective than usual care (routine counseling) in achieving adherence to prescribed blood pressure medications at 12 months.
The project aims to: 1) determine whether patients who receive motivational interview counseling have greater reduction in both systolic and diastolic blood pressure than those in the control group at 12 months. Clinic blood pressure readings will be assessed at baseline and at every three months thereafter for one year and 2) assess the effect of self-efficacy and intrinsic motivation as potential mediators of motivational interview on adherence. Self-efficacy and intrinsic motivation will be assessed at baseline and every three months thereafter for one year.
- Conditions
- Essential Hypertension
- Being tested
- Motivational Interviewing
- Keywords
- Hypertension, African Americans, Adherence, Motivational Interviewing
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Trained nurses will interview the group using motivational interview counseling techniques. All sessions will be conducted with the aid of an adapted version of a standardized structured adherence counseling script. This script was specifically developed for use in medication adherence studies of HIV positive patients and has been provided for this trial.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview Condition | Experimental | Trained nurses will interview the group using motivational interview counseling techniques. All sessions will be conducted with the aid of an adapted version of a standardized structured adherence counseling script. This script was specifically developed for use in medication adherence studies of HIV positive patients and has been provided for this trial. Receives: Behavioral: Motivational Interviewing |
| Non-supportive Counseling | No intervention | A non-supportive counseling session will consist of regular nurse-patient interaction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Morisky Medication Adherence Scale (MMAS-4)
Adherence to antihypertensive medications will be assessed at baseline and every three months thereafter for one year using a validated 4-item scale developed by Morisky that specifically addresses medication-taking. The scale asks patients to respond "yes" or "no" to a set of 4 questions. A positive response to any question indicates a problem with adherence. Each positive answer is assigned a score of 1. The total possible score is 4 with higher score indicating poorer adherence.
Measured: Up to one year from baseline
Secondary outcomes (3)
Blood pressure readings
Within clinic systolic and diastolic blood pressure readings will be assessed at baseline and at every three months thereafter for one year using a mercury syphgmomanometer.
Measured: Up to one year from baseline
Score on efficacy scale
Self-efficacy will be assessed at baseline and every three months thereafter for one year using a 44-item self-efficacy scale devised based on Bandura's Scale. Patients are asked to rate their confidence in taking their blood pressure medications under a variety of situations that may pose difficulties to them using a 3-point likert response format - 1= not at all sure, 2= somewhat sure, and 3= very sure. A summary score is computed by summing the responses, with higher scores reflecting high self-efficacy.
Measured: Up to one year from baseline
Score on the Treatment Self-Regulation Questionnaire (TSRQ)
Intrinsic motivation will be assessed at baseline and every three months thereafter for one year with aid of TSRQ. It is used to assess the degree to which one's motivation for a particular behavior is relatively autonomous or self-determined. Patients are provided with 15 reasons why they may not take their medications as prescribed and asked to indicate the degree to which each reason is true on a scale of 1 to 7 with 7 been very true.
Measured: Up to one year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionMay 2006
- Study completionSep 2008
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gbenga Ogedegbe, MD, MS, MPH, Principal investigator, CUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208104
- Sponsor's protocol ID
- AAAA0311
- Other IDs
- R01HL069408-03
- Status last verified
- Feb 2013
- First submitted
- 14 Sep 2005
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing in Hypertensive African Americans
- ClinicalTrials.gov ID
- NCT00208104
- Acronym / sponsor ID
- AAAA0311
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, African Americans, Adherence, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2002
- Primary completion
- May 2006 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Sep 2005 (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 project is to study ways to make it more likely that patients will take their blood pressure medicine as recommended by their doctors.
Detailed description
The objective of this randomized control trial is to evaluate, among 190 African-American patients with poorly controlled hypertension followed in a community-based primary care practice, whether motivational interviewing is more effective than usual care (routine counseling) in achieving adherence to prescribed blood pressure medications at 12 months.
The project aims to: 1) determine whether patients who receive motivational interview counseling have greater reduction in both systolic and diastolic blood pressure than those in the control group at 12 months. Clinic blood pressure readings will be assessed at baseline and at every three months thereafter for one year and 2) assess the effect of self-efficacy and intrinsic motivation as potential mediators of motivational interview on adherence. Self-efficacy and intrinsic motivation will be assessed at baseline and every three months thereafter for one year.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview Condition | Experimental | Behavioral: Motivational InterviewingTrained nurses will interview the group using motivational interview counseling techniques. All sessions will be conducted with the aid of an adapted version of a standardized structured adherence counseling script. This script was specifically developed for use in medication adherence studies of HIV positive patients and has been provided for this trial. |
| Non-supportive Counseling | No intervention | –A non-supportive counseling session will consist of regular nurse-patient interaction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The target population consisted of hypertensive African American patients who fulfilled the following eligibility criteria:
- Self-identification as African American
- Age 18 years or older
- Diagnosis of hypertension utilizing ICD-9 codes 401-401.9 (the code for essential hypertension)
- Taking at least one antihypertensive medication
Key exclusion criteria (4 listed)
- Had a diagnosis of cognitive impairment or serious medical condition as determined by their primary physician
- Were unable to give informed consent
- Refused to participate
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 |
|---|---|---|
| Motivational InterviewingTrained nurses will interview the group using motivational interview counseling techniques. All sessions will be conducted with the aid of an adapted version of a standardized structured adherence counseling script. This script was specifically developed for use in medication adherence studies of HIV positive patients and has been provided for this trial. | Behavioural | Motivational Interview Condition |
Primary outcome
Score on Morisky Medication Adherence Scale (MMAS-4)
Time frame: Up to one year from baseline
Adherence to antihypertensive medications will be assessed at baseline and every three months thereafter for one year using a validated 4-item scale developed by Morisky that specifically addresses medication-taking. The scale asks patients to respond "yes" or "no" to a set of 4 questions. A positive response to any question indicates a problem with adherence. Each positive answer is assigned a score of 1. The total possible score is 4 with higher score indicating poorer adherence.
3 secondary outcomes
Blood pressure readings
Time frame: Up to one year from baseline
Score on efficacy scale
Time frame: Up to one year from baseline
Score on the Treatment Self-Regulation Questionnaire (TSRQ)
Time frame: Up to one year from baseline
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
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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.
Gbenga Ogedegbe, MD, MS, MPH principal investigator
CUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Essential Hypertension, run by Columbia 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 7 inclusion and 4 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 18 Feb 2013. 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: PI left institution). 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?
Score on Morisky Medication Adherence Scale (MMAS-4) (time frame: Up to one year from baseline). 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 18 Feb 2013.