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

NCT01839864 | Withdrawn DMC

• 1 other identifier: FMRI Promotora Trial
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

Promotoras; Hispanic Adults; metabolic syndrome; rural; patient attitudes; provider cultural competency; patient activation measure

Outcome Measures

Primary Outcomes (1)

• Change in Patient Activation Measure from baseline to six months and six months to one year

  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.

  study entry, six months, one year

Secondary Outcomes (1)

• Changes in patient attitudes about providers and carefrom baseline to six months and six months to one year

  study entry, six months, and one year

Other Outcomes (1)

• Changes in sequelae associated with metabolic syndrome from baseline to six months and six months to one year

  study entry, six month and one year

Study Arms (1)

Promotora plus standard care model

EXPERIMENTAL

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

Interventions

Promotora plus standard physical screening exam , hemoglobin A1c levels, lipid panels, fasting glucose, height, weight, BMI, Complete Blood Count BEHAVIORAL

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

Promotora plus standard care model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• All others

Sponsors & Collaborators

• Family Medicine Residency of Idaho: lead
• Mountain States Group: collaborator
• Saint Alphonsus Medical Group: collaborator
• Quantified, Inc.: collaborator

Study Sites (3)

Saint Alphonsus Medical Group Caldwell Clinic

Caldwell, Idaho, 83605, United States

Location

Saint Lukes Clinic Jerome

Jerome, Idaho, 83338, United States

Location

St Alphonsus Medical Group Nampa Clinic

Nampa, Idaho, 83686, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Body Height; Weights and Measures; Body Mass Index; Blood Cell Count

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Appearance, Body; Anthropometry; Investigative Techniques; Physiological Phenomena; Growth; Growth and Development; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• James T Girvan, PhD, MPH

  Family Medicine Residency of Idaho

  PRINCIPAL INVESTIGATOR

• James Gardner, MD

  Saint Aphonsus Medical Group and Family Medicine Residency of Idaho Rural Training Track Director

  STUDY DIRECTOR

• Ted Epperly, MD

  Family Medicine Residency of Idaho

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 25, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)