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A Peer Support Program to Enhance Treatment Adherence in Patients With Type 2 DM

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ClinicalTrials.gov Identifier: NCT03294265
Recruitment Status : Enrolling by invitation
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Aguilar, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Peer support sessions Behavioral: Reminders Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Peer Support Program to Enhance Treatment Adherence in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Peer support group

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 sessions

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

Behavioral: Reminders

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.

Active Comparator: Control group

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

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.




Primary Outcome Measures :
  1. Glycated hemoglobin [ Time Frame: 1 year ]
    A value of less than 7%


Secondary Outcome Measures :
  1. Triglycerides [ Time Frame: 1 year ]
    A value of less than 150 mg/dl

  2. Blood pressure [ Time Frame: 1 year ]
    A value of less than 130/80 mmHg

  3. Non-HDL cholesterol [ Time Frame: 1 year ]
    A value of less than 130 mg/dl

  4. Weight [ Time Frame: 15 months ]
    Maintenance of an appropriate weight or a 10% weight reduction in overweight or obese patients from the first to the fifth visit

  5. Hypoglycemia events [ Time Frame: 1 year ]
    Reduction of the number of hypoglycemia events

  6. Emergency attendance [ Time Frame: 1 year ]
    Reduction of the number of attendances to the emergency rooms

  7. Foot care [ Time Frame: 1 year ]
    Increase in the number of days the patients check their feet



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-attendance to more than one session

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294265


Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Ana Cristina García Ulloa, Dr. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications of Results:

Responsible Party: Carlos Aguilar, Coordinator of the Research Unit in Metabolic Diseases at the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03294265     History of Changes
Other Study ID Numbers: 1853
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carlos Aguilar, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Diabetes
Peer support
WhatsApp

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases