HypertensionNCT00207194
Interactive Multirisk-Factor Intervention for Hypertension (HTN) Blacks
A study testing Automated Telephone Program and Health Behavior Education in people with Hypertension, run by Boston Medical Center at 1 site in United States.
Trial summary
The aim of this study is to assess the efficacy of Telephone-Linked_Care for Hypertension Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a computer-based telecommunication system that will monitor, educate and counsel African American adults with hypertension on adherence to… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Automated Telephone Program and Health Behavior Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 337 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Aug 2007
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a patient with a primary care provider at one of Boston Medical Center's Adult Primary Care Medical Practices or one of three HealthNet health centers participating in the study
- have a physician diagnosis of hypertension
- be African American by self-report
- be 35 years of age or older
- be prescribed at least one medication for hypertension
- have poorly controlled blood pressure
Show all 9Show fewer
- be non-adherent to at least one hypertensive medication
- understand spoken English
- have a home telephone
Who cannot join
- patients for whom a medication, diet or exercise regiment adherence improvement or maintenance program would be inappropriate
- patients with a terminal illness
- patients with severe medical or psychiatric illness
- patients with cognitive difficulty
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Information Systems Unit/Boston Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Interactive Multirisk-Factor Intervention for HTN Blacks
The aim of this study is to assess the efficacy of Telephone-Linked_Care for Hypertension Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a computer-based telecommunication system that will monitor, educate and counsel African American adults with hypertension on adherence to medication, diet, and exercise. The primary hypotheses are:
- TLC-HTN-AA use will improve medication regiment adherence
- TLC-HTN-AA will improve adherence to 3 healthy diet recommendations
- TLC-HTN-AA will improve levels of regular exercise
- Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regiments than patients in the control group
- Conditions
- Hypertension
- Being tested
- Automated Telephone Program, Health Behavior Education
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Telephone ProgramBehavioural
The intervention incorporated principles of social cognitive theory, the transtheoretical model of behavioral change, and motivational interviewing, and was tailored to the user's values. Content was also adapted to cultural characteristics of culturally African-American adults (i.e., not Caribbean-American, Black-Hispanic, etc.). These participants also received the same health behavior education those in the control condition received.
Health Behavior EducationBehavioural
Participants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01).
| Study group | Role | What they receive |
|---|---|---|
| Automated Telephone Program | Active comparator | The intervention was a totally automated, computer-based, interactive telephone counseling system called Telephone- Linked-Care, designed to monitor, educate, and counsel African-American adults with hypertension and to provide summary data regularly to the patient's primary care provider. Receives: Behavioral: Automated Telephone Program; Behavioral: Health Behavior Education |
| Health Behavior Education | Placebo comparator | The comparator group received health education relating to the management of hypertension. Members of this group also received standard primary medical care. Receives: Behavioral: Health Behavior Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-proportion of study subjects who achieve adequate adherence (greater than or equal to 80% of doses taken) at the end of the intervention period
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
Measured: 8 months
2-consumption of more than 5 servings of fruits and vegetables a day, less than 30% of calories from fat, and less than 2400 mg of sodium a day at the end of the intervention period
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
Measured: 8 months
3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
Measured: 8 months
Secondary outcomes (1)
1-TLC-HTN-AA use will reduce the mean blood pressure and the proportion of the treatment group having uncontrolled hypertension at the end of the intervention period
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
Measured: 8 months
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 startOct 2001
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien Dedier, Boston Medical Center
- Investigators
- Robert Friedman, MD, Principal investigator, Boston Medical CenterJeffrey Migneault, PhD, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207194
- Sponsor's protocol ID
- HL 69395
- Status last verified
- Jun 2016
- First submitted
- 12 Sep 2005
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Migneault JP, Dedier JJ, Wright JA, Heeren T, Campbell MK, Morisky DE, Rudd P, Friedman RH. A culturally adapted telecommunication system to improve physical activity, diet quality, and medication adherence among hypertensive African-Americans: a randomized controlled trial. Ann Behav Med. 2012 Feb;43(1):62-73. doi: 10.1007/s12160-011-9319-4.
PubMed 22246660
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Multirisk-Factor Intervention for HTN Blacks
- ClinicalTrials.gov ID
- NCT00207194
- Acronym / sponsor ID
- HL 69395
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (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 aim of this study is to assess the efficacy of Telephone-Linked_Care for Hypertension Regimen Adherence in an African American population (TLC-HTN-AA). TLC-HTN-AA is a computer-based telecommunication system that will monitor, educate and counsel African American adults with hypertension on adherence to medication, diet, and exercise. The primary hypotheses are:
- TLC-HTN-AA use will improve medication regiment adherence
- TLC-HTN-AA will improve adherence to 3 healthy diet recommendations
- TLC-HTN-AA will improve levels of regular exercise
- Patients receiving TLC-HTN-AA will be more likely to become adherent to all 3 target regiments than patients in the control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated Telephone Program | Active comparator | Behavioral: Automated Telephone Program, Behavioral: Health Behavior EducationThe intervention was a totally automated, computer-based, interactive telephone counseling system called Telephone- Linked-Care, designed to monitor, educate, and counsel African-American adults with hypertension and to provide summary data regularly to the patient's primary care provider. |
| Health Behavior Education | Placebo comparator | Behavioral: Health Behavior EducationThe comparator group received health education relating to the management of hypertension. Members of this group also received standard primary medical care. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- a patient with a primary care provider at one of Boston Medical Center's Adult Primary Care Medical Practices or one of three HealthNet health centers participating in the study
- have a physician diagnosis of hypertension
- be African American by self-report
- be 35 years of age or older
- be prescribed at least one medication for hypertension
Key exclusion criteria (4 listed)
- patients for whom a medication, diet or exercise regiment adherence improvement or maintenance program would be inappropriate
- patients with a terminal illness
- patients with severe medical or psychiatric illness
- patients with cognitive difficulty
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 |
|---|---|---|
| Automated Telephone ProgramThe intervention incorporated principles of social cognitive theory, the transtheoretical model of behavioral change, and motivational interviewing, and was tailored to the user's values. Content was also adapted to cultural characteristics of culturally African-American adults (i.e., not Caribbean-American, Black-Hispanic, etc.). These participants also received the same health behavior education those in the control condition received. | Behavioural | Automated Telephone Program |
| Health Behavior EducationParticipants received a 75-page resource manual that described hypertension, listed dietary recommendations, heart healthy food recipes, and local resources for exercise, and provided information to support antihypertensive medication adherence. They received a 20-min education session based on the content of this manual, and were given a pedometer and a digital weight scale (Healthometer, model # HDR900KD01). | Behavioural | Automated Telephone Program, Health Behavior Education |
Primary outcome
1-proportion of study subjects who achieve adequate adherence (greater than or equal to 80% of doses taken) at the end of the intervention period
Time frame: 8 months
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
2-consumption of more than 5 servings of fruits and vegetables a day, less than 30% of calories from fat, and less than 2400 mg of sodium a day at the end of the intervention period
Time frame: 8 months
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
3-adherence to CDC-ACSM recommendations for moderate intensity physical activity at the end of the intervention period
Time frame: 8 months
Outcomes were assessed at baseline, 4 months, 8 months (the end of the study intervention) and 12 months.
1 secondary outcome
1-TLC-HTN-AA use will reduce the mean blood pressure and the proportion of the treatment group having uncontrolled hypertension at the end of the intervention period
Time frame: 8 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 16 Jun 2016.
- Results publication: PubMed 22246660Migneault JP, Dedier JJ, Wright JA, Heeren T, Campbell MK, Morisky DE, Rudd P, Friedman RH. A culturally adapted telecommunication system to improve physical activity, diet quality, and medication adherence among hypertensive African-Americans: a randomized controlled trial. Ann Behav Med. 2012 Feb;43(1):62-73. doi: 10.1007/s12160-011-9319-4.
Related trials for Hypertension
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruitingPhase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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.
Robert Friedman, MD principal investigator
Boston Medical Center
Jeffrey Migneault, PhD study director
Boston 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 Automated Telephone Program and Health Behavior Education in people with Hypertension, run by Boston Medical Center 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 9 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: finished, as of the sponsor's last update on 16 Jun 2016. 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?
1-proportion of study subjects who achieve adequate adherence (greater than or equal to 80% of doses taken) at the end of the intervention period (time frame: 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00207194, which also lists 1 linked publication.
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 16 Jun 2016.