Insights for Community Health

NCT01681862 | Completed DMC

• 2 other identifiers: 1R21HS020982-01A112-01040
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

High blood pressure is the number one cause of death for Blacks in the United States. A major reason for the high rates of cardiovascular deaths is poor blood pressure control. Improving blood pressure control leads to large reductions in cardiovascular deaths in Blacks and can be achieved through interventions targeting self-management behaviors. Yet, despite the proven benefits of these interventions, there is little evidence of their role in community-based settings. In NYC, the Department of Health and Mental Hygiene (DOHMH) has developed Keep on Track, a volunteer-run, community program that aims to lower blood pressure of older adults through blood pressure monitoring sessions, brief counseling and health education. With support from DOHMH, lay health workers at faith-based organizations and senior centers take blood pressure readings for community members, record their readings on index cards and provide counseling to support lifestyle change and health care access. However, lay health workers administrating the program report difficulties managing the volume of tracking cards, and express interest in better tools to manage the information. To address this limitation, the primary aim of this study is to test the feasibility of implementing a Personal Health Record (PHR) system in two predominately Black churches in NYC to help lay health workers track changes in blood pressure and health behaviors of the participating congregants. The secondary aims are to evaluate the effect of the PHR system on changes in blood pressure, physical activity, weight loss, fruit and vegetable intake, and number of visits to a primary care physician from baseline to 9 months. The investigators hypothesize that congregants who enroll in the PHR system will have a greater reduction in BP; an increased intake of fruits and vegetables and levels of physical activity; weight loss; and report a great number of visits to their doctor at 9 months.

Conditions

Hypertension

Keywords

Hypertension; African American; Personal Health Record; Faith-based Organizations

Outcome Measures

Primary Outcomes (1)

• Feasibility assessment

  RE-AIM framework and ongoing formative evaluation

  2 years

Secondary Outcomes (1)

• Blood pressure

  9 months

Other Outcomes (4)

• Daily servings of fruits and vegetables

  9-months

• Physical Activity

  9 months

• Weight loss

  9-months

Study Arms (1)

Personal Health Record

EXPERIMENTAL

Participants data collected during the scheduled blood pressure sessions will be uploaded to the church PHR system. Lay health workers (LHWs) will then have the capability to access the blood pressure readings and health behavior data through the Congregational Dashboard where they can display the information in easy-to-read charts and graphs that highlight the blood pressure trends across the measurements and changes in fruit and vegetable intake, level of physical activity and weight. The registry will also incorporate computerized health education modules through and evidence-based guidelines for blood pressure control and the NHLBI publications "Your Guide to Lowering Blood Pressure" and "Facts about the DASH Eating Plan."

Behavioral: Personal Health Record

Interventions

Personal Health Record BEHAVIORAL

Participants data collected during the scheduled blood pressure sessions will be uploaded to the church PHR system. Lay health workers (LHWs) will then have the capability to access the blood pressure readings and health behavior data through the Congregational Dashboard where they can display the information in easy-to-read charts and graphs that highlight the blood pressure trends across the measurements and changes in fruit and vegetable intake, level of physical activity and weight. The registry will also incorporate computerized health education modules through and evidence-based guidelines for blood pressure control and the NHLBI publications "Your Guide to Lowering Blood Pressure" and "Facts about the DASH Eating Plan."

Personal Health Record

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years old;
• Are a member of the congregation at one of the participating churches;
• Self-identify as African American/Black and
• Have a diagnosis of HTN (either by self-report or taking at least one antihypertensive medication).

You may not qualify if:

• Inability to comply with the study protocol (either self-selected or by indicating during the consent procedures that s/he cannot complete all requested tasks) or
• Has a serious comorbid medical condition (e.g., psychiatric illness, cognitive impairment due to stroke, dementia, Alzheimer's, etc.).

Sponsors & Collaborators

• NYU Langone Health: lead
• New York City Department of Health and Mental Hygiene: collaborator

Study Sites (2)

NYC Department of Health and Mental Hygiene

New York, New York, 10013, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Health Records, Personal

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques

Study Officials

• Antoinette Schoenthaler, EdD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 10, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

US (2)