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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03294265
• Other study ID #: 1853
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 22, 2017
• Last updated: September 26, 2017
• Start date: August 1, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: September 2017
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Reinforcement of the metabolic control goals and most common problems in diabetes.

2. Self-care activities: detection and appropriate treatment of hypoglycemia, glucose self-monitoring, foot care and actions on concomitant diseases.

3. Adherence to meal plan

4. Structuration of activities to increase physical activity or diminish sedentarism and measurement methods (steps per day, identification of exercise intensity levels)

5. Emotional aspects of diabetes (duel and motivation stages)

6. 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:

1. Identification of motivation and duel stages

2. Reinforcement of metabolic control goals

3. Self-care activities:detection and appropriate treatment of hypoglycemia, glucose self-monitoring, foot care and actions on concomitant diseases and insulin application.

4. Enhancement of adhesion to simplified meal plan and recognition of portions

5. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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
• 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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (9)

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:S9-17. doi: 10.1370/afm.1807. — View Citation

Daaleman TP, Fisher EB. Enriching Patient-Centered Medical Homes Through Peer Support. Ann Fam Med. 2015 Aug;13 Suppl 1:S73-8. doi: 10.1370/afm.1761. — View 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. — View 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. 2 — View 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 — View 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. — View 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:S59 — View 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: 10.1177/01 — View 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 controll — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin	A value of less than 7%	1 year
Secondary	Triglycerides	A value of less than 150 mg/dl	1 year
Secondary	Blood pressure	A value of less than 130/80 mmHg	1 year
Secondary	Non-HDL cholesterol	A value of less than 130 mg/dl	1 year
Secondary	Weight	Maintenance of an appropriate weight or a 10% weight reduction in overweight or obese patients from the first to the fifth visit	15 months
Secondary	Hypoglycemia events	Reduction of the number of hypoglycemia events	1 year
Secondary	Emergency attendance	Reduction of the number of attendances to the emergency rooms	1 year
Secondary	Foot care	Increase in the number of days the patients check their feet	1 year