NCT02874547

Brief Summary

Community Health Workers (CHWs) using patient stories to support hypertension management is a randomized controlled trial to evaluate the implementation of a CHW-delivered culturally appropriate storytelling intervention for english and spanish-speaking patients diagnosed with hypertension who receive care at community health center settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2016

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

August 17, 2016

Last Update Submit

October 23, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • changes in systolic and diastolic BP (SBP and DBP)

    Entering SBP and DBP will be the most recent BP values in the 6 months before entry; exit BP values will be the average of two BP values taken at study exit.

    6 months

Secondary Outcomes (4)

  • Reduce sodium intake

    6 months

  • Increased physical activity

    6 months

  • Greater medication adherence

    6 months

  • Blood Pressure maintenance

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Patients will receive five visits with a CHW during a 6 month period (two in-person and three by telephone). At the first visit, patients will meet the CHW who is trained in motivational interviewing techniques to deliver coaching to work on behavioral changes and introduce a 60 minute Digital Video Disc of five patient stories of individuals who have managed to control their hypertension.

Behavioral: Intervention

Delayed Intervention

OTHER

Patients will receive print materials at time of consent and randomization. Four to six months after randomization, DI patients will receive an invitation to schedule an in-person visit at the health center to begin receiving the intervention protocol.

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

During an in-person visit, patients receive a pamphlet in english and spanish and a storytelling Digital Versatile Disc (DVD) (developed for this project from interviews with hypertensive patients), supplemented by motivational interviewing delivered by the CHW. The CHW explores the patient's motivation to change associated with hypertension and counsels on risk factor control (tobacco, diet, physical activity). Patients receive a followup telephone call from the CHW in 2 weeks, 4 weeks, 2 months to support any changes or goals discussed at first visit. Six months after first intervention visit, patients are invited to schedule an in-person visit with the CHW at the health center to discuss goals and provide support for change.

Delayed InterventionIntervention

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English and Spanish speaking patients
  • Male or female between the ages of 30 and 80
  • Diagnosis of HTN and uncontrolled HTN, defined as (a) having an average systolic BP greater than or equal to 140 and /or diastolic BP greater than or equal to 90 over the past 12 months or (b) most recent BP reading within the previous 6 months as systolic BP greater than or equal to 140 and /or diastolic BP greater than or equal to 90.
  • Willingness to be randomized to either intervention or delayed intervention

You may not qualify if:

  • Pregnant women
  • Patients planning to leave the Community Health Center in the next year
  • Adults unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lowell Community Health Center

Lowell, Massachusetts, 01852, United States

Location

Family Health Center of Worcester

Worcester, Massachusetts, 01655, United States

Location

Related Publications (6)

  • Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA. 2010 May 26;303(20):2043-50. doi: 10.1001/jama.2010.650.

    PMID: 20501926BACKGROUND

  • Ostchega Y, Dillon CF, Hughes JP, Carroll M, Yoon S. Trends in hypertension prevalence, awareness, treatment, and control in older U.S. adults: data from the National Health and Nutrition Examination Survey 1988 to 2004. J Am Geriatr Soc. 2007 Jul;55(7):1056-65. doi: 10.1111/j.1532-5415.2007.01215.x.

    PMID: 17608879BACKGROUND

  • McWilliams JM, Meara E, Zaslavsky AM, Ayanian JZ. Differences in control of cardiovascular disease and diabetes by race, ethnicity, and education: U.S. trends from 1999 to 2006 and effects of medicare coverage. Ann Intern Med. 2009 Apr 21;150(8):505-15. doi: 10.7326/0003-4819-150-8-200904210-00005.

    PMID: 19380852BACKGROUND

  • Swider SM. Outcome effectiveness of community health workers: an integrative literature review. Public Health Nurs. 2002 Jan-Feb;19(1):11-20. doi: 10.1046/j.1525-1446.2002.19003.x.

    PMID: 11841678BACKGROUND

  • Houston TK, Allison JJ, Sussman M, Horn W, Holt CL, Trobaugh J, Salas M, Pisu M, Cuffee YL, Larkin D, Person SD, Barton B, Kiefe CI, Hullett S. Culturally appropriate storytelling to improve blood pressure: a randomized trial. Ann Intern Med. 2011 Jan 18;154(2):77-84. doi: 10.7326/0003-4819-154-2-201101180-00004.

    PMID: 21242364BACKGROUND

  • Hargraves JL, Bonollo D, Person SD, Ferguson WJ. A randomized controlled trial of community health workers using patient stories to support hypertension management: Study protocol. Contemp Clin Trials. 2018 Jun;69:76-82. doi: 10.1016/j.cct.2018.04.004. Epub 2018 Apr 12.

    PMID: 29654929DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Methods

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Warren Ferguson, M.D.

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chair, Department of Family Medicine and Community Health

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

April 14, 2014

Primary Completion

September 14, 2016

Study Completion

December 29, 2016

Last Updated

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)