Counseling Older Adults to Control Hypertension

Hypertension Clinical Trial

— COACH  

Official title:

Counseling Older Adults to Control Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180673
• Other study ID #: 08-416
• Secondary ID: P60MD000206
• Status: Completed
• Phase: Phase 3
• Start date: February 2008
• Est. completion date: December 2012

Study information

• Verified date: March 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effect of a senior center-based comprehensive therapeutic lifestyle intervention delivered through group-based counseling and motivational interviewing (MINT-TLC) among 250 hypertensive African American or Latino seniors age 60 and older in a randomized control trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age 60 years or older

• Diagnosis of HTN

• Taking at least one anti-hypertensive medication

• Self-identified Black, African American, or Latino

Exclusion Criteria:

• Unable to comply with the study protocol

• Participation in other hypertension studies

• Severe hearing impairment

• Severe visual impairment

• Arm circumference > 42 cm for large cuff, or arm circumference > 52 cm for extra large cuff (if extra large cuff is available)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

Behavioral:
• MINT-TLC
This intervention is based on established clinical practice guidelines for prevention and treatment of hypertension, which recommend weight loss (if overweight), limiting sodium and alcohol intake, regular physical activity, and eating a low-fat diet that is rich in fruit and vegetables. Seniors will attend weekly group classes conducted by trained research assistants for the first 12 weeks (intensive phase); followed by three individual motivational interview (MINT) sessions that will occur monthly over the next three months (extended phase); and finally each senior will receive three bi-monthly booster MINT sessions in the remaining six months (maintenance phase).
• Control Condition
Seniors randomized to the control arm will receive a single individual brief advice session on therapeutic lifestyle changes recommended for blood pressure reduction. In addition, they will be given print versions of the NHLBI publications "Your Guide to Lowering Blood Pressure"; and "Facts about the DASH Eating Plan." Sessions will be delivered by trained research assistants.

Locations

Country	Name	City	State
United States	Senior Centers affiliated with NYC Department for the Aging	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	Columbia University, National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Within-individual change in systolic blood pressure and diastolic blood pressure from baseline to 12 months		12 months
Secondary	Change in physical activity level from baseline to 12 months	Physical activity is assessed using the Yale Physical Activity Scale (YPAS) and the International Physical Activity Questionnaire (IPAQ). Data collected with the YPAS will be reported as a final total activity dimension score. Data collected for the IPAQ will be expressed in MET-min per day or categorically (low, moderate, high).	12 months
Secondary	Percent change in weight from baseline to 12 months		12 months
Secondary	Change in number of daily servings of fruits and vegetables from baseline to 12 months		12 months
Secondary	Proportion of participants with adequate blood pressure control at 12 months		12 months