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Completed

NCT Number: NCT02874547

Community Health Workers Using Patient Stories to Support Hypertension Management

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lowell Community Health Center, Lowell, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Community Health Workers Using Patient Stories to Support Hypertension

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2016
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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