Insights for Community Health

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
New York City Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Antoinette Schoenthaler, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01681862
First received: September 5, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Personal Health Record

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insights for Community Health

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Feasibility assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    RE-AIM framework and ongoing formative evaluation


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Blood pressure readings will be taken by trained LHWs using a well-validated automated BP monitor. One of the critical factors in this study is the measurement of BP in the church setting. We will select a validated blood pressure monitor that avoids observer bias, can take a series of readings while the patient is seated quietly, and has the capability of uploading the readings into the PHR. In keeping with KOT and AHA guidelines, patients will be seated quietly with an appropriately sized cuff on the non-dominant arm. The device will be programmed to take three readings at one minute intervals, after an initial rest period of five minutes. The average of three readings will be used as the BP measure for each visit.


Other Outcome Measures:
  • Daily servings of fruits and vegetables [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    Fruit and vegetable intake will be assessed using the 36-item measure developed by Resnicow et al. and validated in a large sample of Black adults participating in the Eat for Life church-based trial. The measure is based on the Health Habits and History Questionnaire and was tailored to foods commonly eaten within the Black population. Participants are asked to indicate number of times that they ate each item in the last seven days and the amount of food (1/2 cup, 1 cup). Portion size is fixed to a medium serving size. The measure will be administered at the baseline and 9-month follow-up visit.

  • Physical Activity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Physical activity will be assessed with the 7-item International Physical Activity Questionnaire (IPAQ)-short version. The short-IPAQ assesses the amount of health-related vigorous and moderate-intensity physical activity as well as sedentary behaviors in adults over a one week period. The number of hours and minutes per day participants report spending in various types of physical activity is multiplied by the average metabolic equivalent (METs) of each category and summed to calculate energy expenditure as kcal/kg/minutes/week. The IPAQ's reliability and validity is well-established in diverse populations. The measure will be administered at the baseline and 9-month follow-up visit.

  • Weight loss [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    Weight will be measured without shoes and with light clothes using a validated digital scale. Measurements will be recorded to the nearest 0.1 kg.

  • Number of visits to the primary care physician [ Time Frame: 9-months ] [ Designated as safety issue: No ]
    Number of visits to a PCP will be assessed with a validated single-item developed by the Stanford Research Center. The measure is designed to serve as a proxy for healthcare utilization in the past 6 months and will assist in determining whether the PHR program facilitated coordination of care across the community and clinic settings. Participant that report seeing their PCP will also be asked if they shared their PHR BP tracking reports with the physician. The measure will be administered at the baseline and 9-month follow-up visit.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Personal Health Record
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
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."

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681862

Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
NYC Department of Health and Mental Hygiene
New York, New York, United States, 10013
Sponsors and Collaborators
New York University School of Medicine
New York City Department of Health and Mental Hygiene
Investigators
Principal Investigator: Antoinette Schoenthaler, EdD NYU School of Medicine
  More Information

No publications provided

Responsible Party: Antoinette Schoenthaler, Assistant Professor of Medicine, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01681862     History of Changes
Other Study ID Numbers: 1R21HS020982-01A1, 12-01040
Study First Received: September 5, 2012
Last Updated: July 10, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Hypertension
African American
Personal Health Record
Faith-based Organizations

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014