Type 2 Diabetes MellitusNCT03294265
A Peer Support Program to Enhance Treatment Adherence in Patients With Type 2 DM
A study testing Peer support sessions and Reminders in people with Type 2 Diabetes Mellitus, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Peer support sessions and Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2016to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Non-attendance to more than one session
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14000
About this study
Official title: 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.
Read the 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
- 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Peer support sessions, Reminders
- Keywords
- Diabetes, Peer support, WhatsApp
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support sessionsBehavioural
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
RemindersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peer support sessions; Behavioral: 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 Receives: Behavioral: Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
A value of less than 7%
Measured: 1 year
Secondary outcomes (7)
Triglycerides
A value of less than 150 mg/dl
Measured: 1 year
Blood pressure
A value of less than 130/80 mmHg
Measured: 1 year
Non-HDL cholesterol
A value of less than 130 mg/dl
Measured: 1 year
Weight
Maintenance of an appropriate weight or a 10% weight reduction in overweight or obese patients from the first to the fifth visit
Measured: 15 months
Hypoglycemia events
Reduction of the number of hypoglycemia events
Measured: 1 year
Emergency attendance
Reduction of the number of attendances to the emergency rooms
Measured: 1 year
Foot care
Increase in the number of days the patients check their feet
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start1 Aug 2016
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Aguilar, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Ana Cristina García Ulloa, Dr., Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294265
- Sponsor's protocol ID
- 1853
- Status last verified
- Sep 2017
- First submitted
- 22 Sep 2017
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26304975Ayala 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.
PubMed 26304977de 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.
PubMed 24593296van 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.
PubMed 24690511Fisher 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.
PubMed 26304968Ghorob 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.
PubMed 21457567Goldman 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.
PubMed 24168838Knox 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.
PubMed 26304973Murray 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.
PubMed 22491396
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer Support Program to Enhance Treatment Adherence in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03294265
- Acronym / sponsor ID
- 1853
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Peer support, WhatsApp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Peer support group | Experimental | Behavioral: Peer support sessions, Behavioral: RemindersPatients 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. |
| Control group | Active comparator | Behavioral: RemindersPatients 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Leaders:
- Completion of the fifth visit and fulfillment of the following criteria:
- HbA1c <7%
- Triglycerides <150 mg/dl
- Non-HDL cholesterol <130 mg/dl
Key exclusion criteria (1 listed)
- Non-attendance to more than one session
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer support sessionsStages 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 | Behavioural | Peer support group |
| RemindersCreation 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. | Behavioural | Control group, Peer support group |
Primary outcome
Glycated hemoglobin
Time frame: 1 year
A value of less than 7%
7 secondary outcomes
Triglycerides
Time frame: 1 year
Blood pressure
Time frame: 1 year
Non-HDL cholesterol
Time frame: 1 year
Weight
Time frame: 15 months
Hypoglycemia events
Time frame: 1 year
Emergency attendance
Time frame: 1 year
Foot care
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- Results publication: PubMed 26304975Daaleman 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 publication: PubMed 26304977Ayala 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 publication: PubMed 24593296de 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 publication: PubMed 24690511van 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 publication: PubMed 26304968Fisher 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 publication: PubMed 21457567Ghorob 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 publication: PubMed 24168838Goldman 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 publication: PubMed 26304973Knox 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 publication: PubMed 22491396Murray 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Cristina García Ulloa, Dr. principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support sessions and Reminders in people with Type 2 Diabetes Mellitus, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294265, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2017.