Utilizing a Promotora Model for Rural Adult Hispanics Diagnosed With Metabolic Syndrome: A Clinical Trial (FMRIMetSynd)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Family Medicine Residency of Idaho
Sponsor:
Collaborators:
Mountain States Group
Saint Alphonsus Medical Group
Quantified, Inc.
Information provided by (Responsible Party):
Family Medicine Residency of Idaho
ClinicalTrials.gov Identifier:
NCT01839864
First received: April 18, 2013
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

The study aims are to test whether the use of promotoras significantly impacts the health attitudes, health seeking behaviors, and patient confidence in self-managing health of rural Hispanic adults who have been diagnosed with metabolic syndrome. Specifically, the study is designed to address four areas of inquiry: 1) identification of patient attitudes involving: a) trust in medical providers and in the health care system, b) procedural fairness in treatment, c) provider and patient communication patterns, d) potential cultural bias in treatment, and e) healthy lifestyle behavior adoption/maintenance, 2) selected clinical indicators of metabolic syndrome (blood pressure, height/weight/BMI, blood glucose, hemoglobin A1c, and cholesterol), 3) the cultural competence of medical providers from the perspective of both the provider and the patient, and 4) patient self-management confidence scores.


Condition Intervention
Metabolic Syndrome
Behavioral: Promotora plus standard physical screening exam , hemoglobin A1c levels, lipid panels, fasting glucose, height, weight, BMI, Complete Blood Count

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Utilizing a Promotora Model for Rural Adult Hispanics Diagnosed With Metabolic Syndrome: A Clinical Trial

Resource links provided by NLM:


Further study details as provided by Family Medicine Residency of Idaho:

Primary Outcome Measures:
  • Change in Patient Activation Measure from baseline to six months and six months to one year [ Time Frame: study entry, six months, one year ] [ Designated as safety issue: No ]
    The patient activation measure (PAM), developed by Hibbard and colleagues, measures patient activation, which has been described as involving four sequential stages: 1) patients believe they have an important role in managing their health, 2) patients possess the necessary knowledge to manage their health, 3) patients take both behavioral and skill-based action to maintain their health, and 4) patients manage their health as best possible under most any circumstance or change in health condition.22 It consists of a 13 item questionnaire which asks respondents to answer "strongly agree", "agree", "disagree" or "strongly disagree" to each item. Scores indicate which of the four stages the respondent is in.


Secondary Outcome Measures:
  • Changes in patient attitudes about providers and carefrom baseline to six months and six months to one year [ Time Frame: study entry, six months, and one year ] [ Designated as safety issue: No ]
    An attitudinal qualitative measures instrument has been derived from a variety of studies, instruments, and theories. The instrument, which features a series of directional attitude statements, consists of 23 statements all of which have Likert Scale response categories "strongly agree", "agree", "disagree", "strongly disagree", and "have not considered". Each of the perspectives/attitudes patients and providers planning this study desired to be measured is reflected in the instrument, i.e., trust in medical providers and the health care system, attitudes about procedural fairness in health care treatment, comfort with seeking care in the health care system, attitudes about communication patterns between physicians and patients, and potential feelings of cultural treatment bias against minorities. The statements are scrambled so that respondents will not pick up a pattern, and attitude perception scores are tallied by combining scores from like items.


Other Outcome Measures:
  • Changes in sequelae associated with metabolic syndrome from baseline to six months and six months to one year [ Time Frame: study entry, six month and one year ] [ Designated as safety issue: No ]

    A reduction in sequelae associated with metabolic syndrome

    1. Fewer patients will become diabetic
    2. Fewer heart attacks and strokes


Estimated Enrollment: 500
Study Start Date: September 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Promotora plus standard care model
Promotora plus standard physical screening exam, hemoglobin A1c levels, lipid panels, fasting glucose, height, weight, BMI, Complete Blood Count
Behavioral: Promotora plus standard physical screening exam , hemoglobin A1c levels, lipid panels, fasting glucose, height, weight, BMI, Complete Blood Count
Promotora services plus the standard care model will be provided for one randomly assigned cohort of patients meeting the inclusion criteria while the other cohort will receive the standard care model only

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult
  • Rural dwelling Hispanics who have been diagnosed with metabolic syndrome

Exclusion Criteria:

  • All others
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839864

Contacts
Contact: James T Girvan, PhD, MPH 208-830-9762 jgirvan@boisestate.edu
Contact: James Gardner, MD 208-965-5452 jamegard@sarmc.org

Locations
United States, Idaho
Saint Alphonsus Medical Group Caldwell Clinic Not yet recruiting
Caldwell, Idaho, United States, 83605
Contact: Jim Gardner, MD    208-965-5452    jamegard@sarmc.org   
Contact: Kim Clark, MS    208-899-3916    clarkkr@sarmc.org   
Saint Lukes Clinic Jerome Not yet recruiting
Jerome, Idaho, United States, 83338
Contact: Johnna Bailey, AA    208-316-0258    baileyjo@slhs.org   
Contact: Joshua Kern, MD    208-316-0258    KernJW@slhs.org   
St Alphonsus Medical Group Nampa Clinic Not yet recruiting
Nampa, Idaho, United States, 83686
Contact: Keith Forester, MS    208-465-7377    foresterk@sarmc.org   
Contact: Kim Clark, S    208-899-3916    clarkkr@sarmc.org   
Sponsors and Collaborators
Family Medicine Residency of Idaho
Mountain States Group
Saint Alphonsus Medical Group
Quantified, Inc.
Investigators
Principal Investigator: James T Girvan, PhD, MPH Family Medicine Residency of Idaho
Study Director: James Gardner, MD Saint Aphonsus Medical Group and Family Medicine Residency of Idaho Rural Training Track Director
Study Chair: Ted Epperly, MD Family Medicine Residency of Idaho
  More Information

No publications provided

Responsible Party: Family Medicine Residency of Idaho
ClinicalTrials.gov Identifier: NCT01839864     History of Changes
Other Study ID Numbers: FMRI Promotora Trial
Study First Received: April 18, 2013
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Family Medicine Residency of Idaho:
Promotoras
Hispanic Adults
metabolic syndrome
rural
patient attitudes
provider cultural competency
patient activation measure

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014