Clinical trial NCT01681862: Insights for Community Health
Official title: Insights for Community Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
African American
Personal Health Record
Faith-based Organizations
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: New York City Department of Health and Mental Hygiene
First posted: 2012-09-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Poor blood pressure (BP) control is major contributor to the racial disparity in HTN among Blacks; the odds of poor BP control are 40% higher among Blacks as compared to Whites. Improving BP control leads to significant cardiovascular risk reduction in Blacks and can be achieved through evidence-based interventions targeting self-management behaviors that are coordinated with primary care in a "medical neighborhood". Despite the efficacy of these interventions, they are not widely disseminated to community-based settings, or linked as "community resources" to primary care clinics. The challenge for local health departments is to redesign these evidence-based approaches to function at the level of resources and skills available in typical community-based organizations (CBO). Health IT could build the capacity of CBOs to implement evidence-based models, allowing for broader translation of life-saving interventions, and lay a foundation for coordination of care for people with HTN. In New York City, the Department of Health and Mental Hygiene (NYC DOHMH) has developed Keep on Track (KOT) - a volunteer-run program designed to lower BP in older adults through biweekly BP monitoring sessions and health education. With technical and material support from DOHMH, lay health workers (LHW) at senior centers and faith-based organizations take BP readings for community members, record their readings on index cards and provide brief counseling to support lifestyle change and healthcare access. A limitation of the program is the use of paper BP tracking cards, which LHWs find difficult to efficiently review for purposes of targeted outreach and referral. They express interest in alternative tools for information management, which would be more conducive to organized outreach to church members with high BP, to support them in their efforts at lifestyle change and their attempts to gain access to high quality healthcare.

In order to address this important limitation, the investigators will assess the feasibility of implementing a Personal Health Record (PHR) system and Congregational Dashboard customized to support KOT LHWs in two predominately Black churches in NYC to track both individual and aggregate changes in BP and health behaviors among participating congregants. The investigators propose that PHR implementation could improve the capacity of the Health Ministry to manage information and heighten the impact of KOT. Specifically the investigators propose that PHR implementation could improve community-based BP control programs by enabling LHWs to adopt elements of the Chronic Care Model:1) targeted outreach to participating congregants most in need of support for health behavior change; 2) collaborative goal-setting at both the individual and church-level; and 3) empowering members to gain access to healthcare and present physicians with BP tracking reports.

Primary Aim: To assess the feasibility of implementing a customized PHR system to support a church-based BP monitoring program in two predominately Black churches in New York City.

Secondary Aims: To evaluate the effect of implementing the PHR system on:

1. Changes in systolic and diastolic BP from baseline to 9 months
2. Changes in daily servings of fruits and vegetables; level of physical activity; within-participant weight loss; and number of visits to the primary care physician (PCP) from baseline to 9 months

Hypothesis: Congregants who enroll in the PHR system will exhibit a reduction in BP; an increased intake of fruits and vegetables and levels of physical activity; within-participant weight loss; and report a great number of visits to their PCP at 9 months.

Outcomes for the primary and secondary aims will be assessed at the church- and individual-levels. An ongoing formative evaluation will be conducted to identify barriers and facilitators to PHR implementation, and garner suggestions for improvement. Data collected from the formative evaluation will inform necessary system modifications and continuous refinements. A process evaluation will also be conducted with the RE-AIM framework. BP will be assessed with a validated automated BP monitor based on American Heart Association (AHA) guidelines. Health behaviors will be assessed with well-validated self-report measures; weight loss will be estimated as the difference in weight between baseline and 9 months.

Eligibility 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.).

Primary outcomes:
measure: Feasibility assessment
timeFrame: 2 years
Secondary outcomes:
measure: Blood pressure
timeFrame: 9 months
Other outcomes:
measure: Daily servings of fruits and vegetables
timeFrame: 9-months
measure: Physical Activity
timeFrame: 9 months
measure: Weight loss
timeFrame: 9-months
measure: Number of visits to the primary care physician
timeFrame: 9-months
Locations:
city: New York
country: United States
facility: NYC Department of Health and Mental Hygiene
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Antoinette Schoenthaler, EdD
role: PRINCIPAL_INVESTIGATOR
References: