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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

Tracking Information
First Submitted Date  ICMJE August 17, 2016
First Posted Date  ICMJE August 22, 2016
Last Update Posted Date October 25, 2017
Actual Study Start Date  ICMJE April 14, 2014
Actual Primary Completion Date September 14, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
changes in systolic and diastolic BP (SBP and DBP) [ Time Frame: 6 months ]
Entering SBP and DBP will be the average of up to the 3 most recent BP values in the 6 months before entry; exit BP values will be the mean of up to the 3 most recent values in the 6 months prior to study exit.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Reduce sodium intake [ Time Frame: 6 months ]
    Self report of behavior change
  • Increased physical activity [ Time Frame: 6 months ]
    Self report of behavior change
  • Greater medication adherence [ Time Frame: 6 months ]
    Self report of behavior change
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
  • Reduce sodium intake [ Time Frame: 6 months ]
    Self report of behavior change
  • Increased physical activity [ Time Frame: 6 months ]
    Self report of behavior change
  • Greater medication adherence [ Time Frame: 6 months ]
    Self report of behavior change
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community Health Workers Using Patient Stories to Support Hypertension Management
Official Title  ICMJE Community Health Workers Using Patient Stories to Support Hypertension
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Intervention
  • 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.
    Intervention: Behavioral: Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2017)
171
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2016)
252
Actual Study Completion Date  ICMJE December 29, 2016
Actual Primary Completion Date September 14, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02874547
Other Study ID Numbers  ICMJE 5P60MD006912-02( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Warren Ferguson, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Warren Ferguson, M.D. University of Massachusetts, Worcester
PRS Account University of Massachusetts, Worcester
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP