search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Peer support sessions
Reminders
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, Peer support, WhatsApp

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peer support group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Glycated hemoglobin
A value of less than 7%

Secondary Outcome Measures

Triglycerides
A value of less than 150 mg/dl
Blood pressure
A value of less than 130/80 mmHg
Non-HDL cholesterol
A value of less than 130 mg/dl
Weight
Maintenance of an appropriate weight or a 10% weight reduction in overweight or obese patients from the first to the fifth visit
Hypoglycemia events
Reduction of the number of hypoglycemia events
Emergency attendance
Reduction of the number of attendances to the emergency rooms
Foot care
Increase in the number of days the patients check their feet

Full Information

First Posted
September 22, 2017
Last Updated
September 26, 2017
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
search

1. Study Identification

Unique Protocol Identification Number
NCT03294265
Brief Title
A Peer Support Program to Enhance Treatment Adherence in Patients With Type 2 DM
Official Title
A Peer Support Program to Enhance Treatment Adherence in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The traditional model of attention has not been able to face the diabetes epidemic mainly because it is treated like an acute disease instead of like a chronic condition. Given that it requires a continuous and integrated management that cares for all the aspects of the patient's disease, it is fundamental that the patients learn to live with diabetes, and to manage it effectively to improve their life quality and reduce the risks of long term complications. The peer support programs include people who live with the same condition (patients, relatives and friends) who have received training related to their treatment, becoming an important social, emotional and practical support in the daily care of chronic diseases.They become comfortable enough as to share their emotions and experiences with other patients with their same condition. Many studies have shown that the patients with diabetes who commit to provide peer support to others also improve their self-care and glycemic long-term control. The meetings with group leaders consist discussions among the patients where they share experiences and solutions to barriers. The Center of Comprehensive Care for the Patient with Diabetes (CAIPaDi) was created with the objective of investigating about new strategies to promote empowerment, self-efficacy and the reach of metabolic control in order to prevent diabetes complications (protocol "Validation of an integrated attention model for the patient with type 2 diabetes" reference number 1198). The inclusion criteria are: less than 5 years of diagnosis of diabetes, absence of chronic complications, not smoking and having a relative to join them in all the sessions. The program consists of 4 initial visits, one per month, and includes attention from 9 specialties: endocrinology, psychology, nutrition, ophthalmology, diabetes education, odontology, physical activity, foot care and psychiatry. Upon conclusion of the fourth visit, a counter-reference of each patient is sent to their corresponding particular physician. In this report, each specialty explains in a detailed manner the strengths and opportunity areas of the patient. Afterwards, the patient is given an appointment a year after concluding the first phase of the program (visit 5) and a year after this visit (visit 6). Description of the interventions 1. Identification of the "group leaders" Patients who fulfill the eligibility criteria will be invited and asked to sign the informed consent, afterwards they will attend 7 training sessions of 60 minutes each, the following topics will be assessed in each of them: Reinforcement of the metabolic control goals and most common problems in diabetes. Self-care activities: detection and appropriate treatment of hypoglycemia, glucose self-monitoring, foot care and actions on concomitant diseases. Adherence to meal plan Structuration of activities to increase physical activity or diminish sedentarism and measurement methods (steps per day, identification of exercise intensity levels) Emotional aspects of diabetes (duel and motivation stages) Adhesion to pharmacologic treatment (medications and insulin) Each session will be arranged by a team researcher and will be structured in the following way: 10 minutes: reminder of activities and resolution of doubts from the previous session 50 minutes: new subject of each session After the patient has completed the training, an objective structured clinical evaluation will be performed. The patients who approve the evaluation will receive a group management session where they will obtain the necessary skills to motivate and transmit information to the rest of the group. Phase 2: Integration of patient groups All the patients who finish the fourth visit in the centre will be invited, those who accept will be randomized into participants or control patients. Each group will be formed by 2 group leaders and 5 patients. The minimum number of participants per session will be 2 (one leader and one patient). Five sessions are projected, one every 2 months, where the next topics will be reviewed in each of them: Identification of motivation and duel stages Reinforcement of metabolic control goals Self-care activities:detection and appropriate treatment of hypoglycemia, glucose self-monitoring, foot care and actions on concomitant diseases and insulin application. Enhancement of adhesion to simplified meal plan and recognition of portions Structuration of activities to boost physical activity and/or reduce sedentarism and how to measure it (steps per day and identification of exercise intensity levels) Motivational messages and reminders will be created and sent by WhatsApp (cross-platform instant messaging application) weekly to patients, controls and group leaders to strengthen adhesion to integral treatment. Every session will be carried out in the facilities of the centre, where the leaders will share their experiences with the rest of the group to reinforce self-care activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes, Peer support, WhatsApp

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer support group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Peer support sessions
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Reminders
Intervention Description
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 Measure Information:
Title
Glycated hemoglobin
Description
A value of less than 7%
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Triglycerides
Description
A value of less than 150 mg/dl
Time Frame
1 year
Title
Blood pressure
Description
A value of less than 130/80 mmHg
Time Frame
1 year
Title
Non-HDL cholesterol
Description
A value of less than 130 mg/dl
Time Frame
1 year
Title
Weight
Description
Maintenance of an appropriate weight or a 10% weight reduction in overweight or obese patients from the first to the fifth visit
Time Frame
15 months
Title
Hypoglycemia events
Description
Reduction of the number of hypoglycemia events
Time Frame
1 year
Title
Emergency attendance
Description
Reduction of the number of attendances to the emergency rooms
Time Frame
1 year
Title
Foot care
Description
Increase in the number of days the patients check their feet
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Cristina García Ulloa, Dr.
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26304975
Citation
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.
Results Reference
result
PubMed Identifier
26304977
Citation
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.
Results Reference
result
PubMed Identifier
24593296
Citation
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.
Results Reference
result
PubMed Identifier
24690511
Citation
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.
Results Reference
result
PubMed Identifier
26304968
Citation
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.
Results Reference
result
PubMed Identifier
21457567
Citation
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.
Results Reference
result
PubMed Identifier
24168838
Citation
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.
Results Reference
result
PubMed Identifier
26304973
Citation
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.
Results Reference
result
PubMed Identifier
22491396
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs