- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03294265
A Peer Support Program to Enhance Treatment Adherence in Patients With Type 2 DM
A Peer Support Program to Enhance Treatment Adherence in Patients With Type 2 Diabetes Mellitus
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Mexico City, México, 14000
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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. |
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 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. |
Comparador activo: 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 |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Glycated hemoglobin
Periodo de tiempo: 1 year
|
A value of less than 7%
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Triglycerides
Periodo de tiempo: 1 year
|
A value of less than 150 mg/dl
|
1 year
|
Blood pressure
Periodo de tiempo: 1 year
|
A value of less than 130/80 mmHg
|
1 year
|
Non-HDL cholesterol
Periodo de tiempo: 1 year
|
A value of less than 130 mg/dl
|
1 year
|
Weight
Periodo de tiempo: 15 months
|
Maintenance of an appropriate weight or a 10% weight reduction in overweight or obese patients from the first to the fifth visit
|
15 months
|
Hypoglycemia events
Periodo de tiempo: 1 year
|
Reduction of the number of hypoglycemia events
|
1 year
|
Emergency attendance
Periodo de tiempo: 1 year
|
Reduction of the number of attendances to the emergency rooms
|
1 year
|
Foot care
Periodo de tiempo: 1 year
|
Increase in the number of days the patients check their feet
|
1 year
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Ana Cristina García Ulloa, Dr., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1853
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Diabetes mellitus tipo 2
-
AstraZenecaReclutamiento
-
Daewoong Pharmaceutical Co. LTD.Aún no reclutandoDM2 (Diabetes Mellitus Tipo 2)
-
University of ZambiaUniversity Teaching Hospital, Lusaka, ZambiaAún no reclutandoDiabetes Mellitus Tipo 2 Sin Complicaciones
-
Zhongda HospitalReclutamientoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Newsoara Biopharma Co., Ltd.ReclutamientoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
Shanghai Golden Leaf MedTec Co. LtdActivo, no reclutandoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Haisco Pharmaceutical Group Co., Ltd.TerminadoDM2 (Diabetes Mellitus Tipo 2)Porcelana
-
PegBio Co., Ltd.TerminadoDiabetes mellitus tipo 2 (DM2)Porcelana
-
Oramed, Ltd.IntegriumTerminadoDM2 (Diabetes Mellitus Tipo 2)Estados Unidos
Ensayos clínicos sobre Peer support sessions
-
Potomac Health FoundationsNational Institutes of Health (NIH); National Institute of Drug AbuseReclutamientoTrastorno por uso de sustancias | Trastorno por uso de opioidesEstados Unidos
-
MYnd AnalyticsUniversity of Ottawa; Canadian Forces Health Services Centre OttawaDesconocidoDepresión | Diagnóstico no psicótico como comorbilidadCanadá
-
MYnd AnalyticsSuspendido
-
Icahn School of Medicine at Mount SinaiAmerican Heart AssociationTerminadoAterosclerosis | Intervención de estilo de vida | Promoción de la salud cardiovascular en adultosEstados Unidos
-
University of California, Los AngelesTerminado
-
University of OregonReclutamiento
-
Mental Health Services in the Capital Region, DenmarkThe Peer partnership associationTerminadoTrastorno de salud mental | Deterioro de la salud mental | Grupo de pares | Problemas PsicosocialesDinamarca
-
Illinois Institute of TechnologyPatient-Centered Outcomes Research Institute; TrilogyTerminadoDesordenes mentalesEstados Unidos
-
Rhode Island HospitalBrown UniversityTerminadoTrastornos relacionados con opioides | Dependencia de opioides | Uso de opioides | Abuso de opioidesEstados Unidos
-
Western University, CanadaProvidence Care Hospital, Kingston, ON, Canada; Trellis HIV and Community Care...Activo, no reclutandoTrastornos por uso de sustancias | Enfermedad mental | Inclusión socialCanadá