NCT02994095

Brief Summary

This was a pilot study to assess the feasibility and acceptability of training Community Health Agents in Motivational Interviewing in real-life primary care centers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
Last Updated

December 15, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 12, 2016

Last Update Submit

December 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • PACIC score

    Quality of Diabetes Care Received

    Six months

Study Arms (1)

Single intervention arm

EXPERIMENTAL

Trained CHAs in Motivational Interviewing in pilot study

Behavioral: Pilot Study

Interventions

Pilot StudyBEHAVIORAL

Trained community health agents used Motivational Interviewing-based counseling and action planning in monthly home visits with adults with diabetes

Single intervention arm

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with T2 diabetes who received care at the primary care center
  • A1c\>7.0% in prior six months

You may not qualify if:

  • Age\> 75
  • being pregnant
  • having terminal health condition or other conditions that would impede participation such as dementia and mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • do Valle Nascimento TM, Resnicow K, Nery M, Brentani A, Kaselitz E, Agrawal P, Mand S, Heisler M. A pilot study of a Community Health Agent-led type 2 diabetes self-management program using Motivational Interviewing-based approaches in a public primary care center in Sao Paulo, Brazil. BMC Health Serv Res. 2017 Jan 13;17(1):32. doi: 10.1186/s12913-016-1968-3.

MeSH Terms

Interventions

Pilot Projects

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesEvaluation Studies as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michele Heisler, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 15, 2016

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

December 15, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

De-identified data set available on request.