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Community Health Workers Using Patient Stories to Support Hypertension Management

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ClinicalTrials.gov Identifier: NCT02874547
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Warren Ferguson, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Intervention Not Applicable

Detailed Description:
Community Health Workers (CHWs) using patient stories to support hypertension (HTN) management is a CHW-delivered culturally appropriate storytelling intervention for patients diagnosed with HTN. We will develop and test interactive videos presenting stories of patients who have successfully made changes enhancing blood pressure control; and integrate this new tool with a CHW approach to management of hypertension. This two site, two-armed randomized controlled trial aims to recruit 252 english and spanish speaking patients with uncontrolled HTN. All participants are randomized to receive five visits (two in-person and 3 telephone calls) with CHWs either immediately (intervention condition (I)) or 6 months after enrollment (delayed intervention (DI)). Intervention participants receive the intervention immediately and DI participants receive print materials at enrollment and are telephoned 4-6 months after enrollment to schedule an in-person visit at the health enter to begin receiving the intervention protocol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community Health Workers Using Patient Stories to Support Hypertension
Actual Study Start Date : April 14, 2014
Actual Primary Completion Date : September 14, 2016
Actual Study Completion Date : December 29, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
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 Intervention
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
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.




Primary Outcome Measures :
  1. changes in systolic and diastolic BP (SBP and DBP) [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Reduce sodium intake [ Time Frame: 6 months ]
    Self report of behavior change

  2. Increased physical activity [ Time Frame: 6 months ]
    Self report of behavior change

  3. Greater medication adherence [ Time Frame: 6 months ]
    Self report of behavior change

  4. Blood Pressure maintenance [ Time Frame: 12 months ]
    SBP and DBP will be the value obtained from the Electronic Health Record visit date 12 months after enrollment



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874547


Locations
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United States, Massachusetts
Lowell Community Health Center
Lowell, Massachusetts, United States, 01852
Family Health Center of Worcester
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Warren Ferguson, M.D. University of Massachusetts, Worcester
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Warren Ferguson, Professor and Vice Chair, Department of Family Medicine and Community Health, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02874547    
Other Study ID Numbers: 5P60MD006912-02 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases