AzTrials
AzTrials

HypertensionNCT01681862

Insights for Community Health

A study testing Personal Health Record in people with Hypertension, run by NYU Langone Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Personal Health Record
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesUnited States
Study dates
Sep 2012to Jul 2015
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.).

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • NYC Department of Health and Mental Hygiene

    New York, New York, 10013

  • NYU School of Medicine

    New York, New York, 10016

Other trials in United States

About this study

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.

Read the 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.

Conditions
Hypertension
Being tested
Personal Health Record
Keywords
Hypertension, African American, Personal Health Record, Faith-based Organizations
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personal Health RecordBehavioural

    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."

Study groups in NCT01681862
Study groupRoleWhat they receive
Personal Health RecordExperimentalParticipants 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."
Receives: Behavioral: Personal Health Record

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility assessment

    RE-AIM framework and ongoing formative evaluation

    Measured: 2 years

Secondary outcomes (1)
  1. Blood pressure

    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.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01681862
Sponsor's protocol ID
1R21HS020982-01A1
Other IDs
12-01040
Status last verified
Oct 2015
First submitted
5 Sep 2012
Last updated
6 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Personal Health Record in people with Hypertension, run by NYU Langone Health at 2 sites 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 4 inclusion and 2 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 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

Feasibility assessment (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Oct 2015.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in