NCT03294265

Brief Summary

Diabetes Mellitus (DM) affects patients' quality of life in different dimensions. Therefore, it is considered a priority to design and create specialized intervention programs in order to prevent and decrease complications. The peer support program studies have shown to Increase adherence to treatment and the proportion of patients with adequate long-term metabolic control. The benefits that these programs bring are the social and emotional support in the daily management of the disease through shared experiences and communication in a continuous way. There are only a few peer support programs in Mexico, thus it is required to investigate the effects of their implementation in our environment to promote empowerment and maintain long-term lifestyle changes. The present study has the objective to enhance self-care behaviors and health empowerment in patients with diabetes through peer support.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

September 22, 2017

Last Update Submit

September 26, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

DiabetesPeer supportWhatsApp

Outcome Measures

Primary Outcomes (1)

  • Glycated hemoglobin

    A value of less than 7%

    1 year

Secondary Outcomes (7)

  • Triglycerides

    1 year

  • Blood pressure

    1 year

  • Non-HDL cholesterol

    1 year

  • Weight

    15 months

  • Hypoglycemia events

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Peer support group

EXPERIMENTAL

Patients who accept to participate in the protocol and are randomized to the intervention group will be invited to five sessions, one per bimester, that will be carried out in our facilities until their next appointment to the centre (fifth visit). All of them will be coordinated by a group leader. Interventions are made each bimester in 2 hours in peer support sessions in which the patients discuss and reinforce the following topics: grief stages, control goals, self-care activities, adequate diet planning and diminish sedentary lifestyle.

Behavioral: Peer support sessionsBehavioral: Reminders

Control group

ACTIVE COMPARATOR

Patients who accept to participate in the protocol and are randomized to the control group will receive weekly messages and reminders about self-care to their cell phones via WhatsApp. Interventions are made by sending each week a self-care reminder via WhatsApp and questionnaires about self-care activities and drugs

Behavioral: Reminders

Interventions

Peer support sessionsBEHAVIORAL

Stages of mourning and motivation Patients introduce themselves, share their experience and mention a strategy on moving on to the next stage Reminder of metabolic control goals Leaders write on the board metabolic variables and ask everybody the goal values. Patients share their results and mention plans to improve them Self-care activities Leaders ask who owns a glucometer, how regularly they use it, its importance and consequences of not doing so. Simplified meal plan Everyone brings a snack. Leaders ask if each snack is appropriate, how everyone carries out their meal plan, barriers and possible strategies Activities to increase physical activity Everyone compares who achieves 10 thousand steps/day and who doesn't, then mention benefits of exercise

Peer support group
RemindersBEHAVIORAL

Creation of a group on WhatsApp to send leaders and patients a weekly reminder on the different areas of self-care, such as foot care, self-monitoring, adherence to meal plan, medication and exercise. This intervention will be applied to both groups.

Control groupPeer support group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Leaders:
  • Completion of the fifth visit and fulfillment of the following criteria:
  • HbA1c \<7%
  • Triglycerides \<150 mg/dl
  • Non-HDL cholesterol \<130 mg/dl
  • Blood pressure \<130/80 mmHg
  • Normal weight or a reduction of 10% since the first visit
  • Approval after a psychiatric and psychologic evaluation
  • Patients:
  • Completion of the fourth visit in the centre
  • Absence of diabetes complications
  • Non-smokers

You may not qualify if:

  • Non-attendance to more than one session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14000, Mexico

Location

Related Publications (9)

  • Daaleman TP, Fisher EB. Enriching Patient-Centered Medical Homes Through Peer Support. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S73-8. doi: 10.1370/afm.1761.

    PMID: 26304975RESULT

  • Ayala GX, Ibarra L, Cherrington AL, Parada H, Horton L, Ji M, Elder JP. Puentes hacia una mejor vida (Bridges to a Better Life): Outcome of a Diabetes Control Peer Support Intervention. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S9-17. doi: 10.1370/afm.1807.

    PMID: 26304977RESULT

  • de Vries L, van der Heijden AA, van 't Riet E, Baan CA, Kostense PJ, Rijken M, Rutten GE, Nijpels G. Peer support to decrease diabetes-related distress in patients with type 2 diabetes mellitus: design of a randomised controlled trial. BMC Endocr Disord. 2014 Mar 4;14:21. doi: 10.1186/1472-6823-14-21.

    PMID: 24593296RESULT

  • van Puffelen AL, Rijken M, Heijmans MJ, Nijpels G, Rutten GE, Schellevis FG. Living with diabetes: a group-based self-management support programme for T2DM patients in the early phases of illness and their partners, study protocol of a randomised controlled trial. BMC Health Serv Res. 2014 Apr 1;14:144. doi: 10.1186/1472-6963-14-144.

    PMID: 24690511RESULT

  • Fisher EB, Ayala GX, Ibarra L, Cherrington AL, Elder JP, Tang TS, Heisler M, Safford MM, Simmons D; Peers for Progress Investigator Group. Contributions of Peer Support to Health, Health Care, and Prevention: Papers from Peers for Progress. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S2-8. doi: 10.1370/afm.1852.

    PMID: 26304968RESULT

  • Ghorob A, Vivas MM, De Vore D, Ngo V, Bodenheimer T, Chen E, Thom DH. The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial. BMC Public Health. 2011 Apr 1;11:208. doi: 10.1186/1471-2458-11-208.

    PMID: 21457567RESULT

  • Goldman ML, Ghorob A, Eyre SL, Bodenheimer T. How do peer coaches improve diabetes care for low-income patients?: a qualitative analysis. Diabetes Educ. 2013 Nov-Dec;39(6):800-10. doi: 10.1177/0145721713505779. Epub 2013 Oct 29.

    PMID: 24168838RESULT

  • Knox L, Huff J, Graham D, Henry M, Bracho A, Henderson C, Emsermann C. What Peer Mentoring Adds to Already Good Patient Care: Implementing the Carpeta Roja Peer Mentoring Program in a Well-Resourced Health Care System. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S59-65. doi: 10.1370/afm.1804.

    PMID: 26304973RESULT

  • Murray NJ, Gasper AV, Irvine L, Scarpello TJ, Sampson MJ. A motivational peer support program for type 2 diabetes prevention delivered by people with type 2 diabetes: the UEA-IFG feasibility study. Diabetes Educ. 2012 May-Jun;38(3):366-76. doi: 10.1177/0145721712440332. Epub 2012 Apr 6.

    PMID: 22491396RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ana Cristina García Ulloa, Dr.

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Non-probabilistic sampling, by convenience (for the leaders). Randomization was performed by random stratified sampling, for which we considered age, sex and metabolic parameters (HbA1c, tryglycerides, blood pressure and body-mass index) of every patient in its fourth visit
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of the Research Unit in Metabolic Diseases at the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Record Dates

First Submitted

September 22, 2017

First Posted

September 27, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 27, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)