- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097483
Treatment Adherence Intervention in Patients With Type 2 Diabetes and Comorbid Depression (TELE-DD)
The TELE-DD Project: a Nurse-led Randomised Controlled Trial on Treatment Adherence in Patients With Type 2 Diabetes and Comorbid Depression
Patients with diabetes have higher depression rates, impaired QOL and increased mortality rates due to complications and comorbid depression. Nurse-led, telephonic-based, and psychoeducational interventions have separately proved to improve disease prognosis and emotional distress in diabetes, but no study has integrated previous research findings with collaborative care and strong methods centred in treatment adherence outcomes. The Telephonic Monitoring on Diabetes and co-morbid Depression (TELE-DD) Project includes a three-phased population-based cohort study and nurse-led randomised controlled trial. The proposed intervention, based on monthly structured telephone calls, unifies proved techniques like motivational interviewing, cognitive behavioural therapy and patient's healthy behaviours education.
The integration in the TELE-DD Project of previous clinical research and a robust epidemiological dual design, will improve treatment adherence and further prognosis in patients with type 2 diabetes and comorbid depression through maximising clinical outcomes improvement, while guaranteeing cost-effectiveness and the long-term sustainability of findings translation to PC clinical practice services and public health programs.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with diabetes mellitus have a depression rate 1.6-2 times higher, impaired quality of life and increased mortality rates due to complications, comorbid depression or both. Prognosis in diabetes and depression comorbidity can be improved by increasing treatment adherence. Nurse-led, telephonic-based, and psychoeducational interventions, centred on motivational interviewing and cognitive behavioural therapy for adherence and depression, have separately improved prognosis and emotional distress in diabetic patients with comorbid depression.
The Telephonic Monitoring on Diabetes and co-morbid Depression (TELE-DD) Project aims to integrate prior well-stablished clinical research with collaborative care. A whole population cohort of adults (21+) with type 2 diabetes (T2D) and comorbid depression from twenty-three Health Centres from a whole Health System Region in Spain, will be approached for inclusion in the TELE-DD Project (N=7,271). Patients with confirmed diagnoses and pharmacological treatment for both diseases will be included in Phase I baseline cohort. In Phase II, 400 participants diagnosed with depression and T2D with no treatment adherence will be selected to participate in the randomised controlled trial (RCT). The TELE-DD Project is a three-stage both observational and comparative effectiveness study that includes a population-based cohort study (Phases I and III), and a nurse-led randomised controlled trial (Phase II), aimed to compare a telephonic-based psychoeducational intervention (TIG) vs treatment as usual (TAU) to improve treatment adherence (TA), and a further two- to five-year prognosis and cost-effectiveness study, in T2D patients with comorbid clinical depression from Primary Care (PC) services.
The integration in the TELE-DD Project of previous clinical research and a robust epidemiological design, will improve treatment adherence and further prognosis in these through maximising clinical outcomes improvement, while guaranteeing cost-effectiveness and the long-term sustainability of findings translation to PC clinical practice services and public health programs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult individuals (21+).
- Concurrent type 2 diabetes (T2D) and depression diagnose registered in the SALUD clinical computerised system before January 1st, 2016.
- A duration of both T2D and depression of at least one year.
- Willingness to follow the TELE-DD research nurse instructions including self-monitoring of blood glucose.
- Fluent in the Spanish language
- Provision of signed and dated informed consent prior to any study procedures.
- No treatment adherence to both T2D and depression, or treatment adherence to both.
Exclusion Criteria:
- Presence of hearing problems, Alzheimer Disease, dementia or another serious cognitive or psychiatric disorder.
- Use of private health insurance that may influence the RCT intervention outcomes.
- Absence of pharmacological treatment for T2D or depression according to the CHS-EMR.
- Change of address or place of residence out of SALUD Zaragoza Region II, or no access to a phone.
- No Primary Care Specialist (PCS) or inability to identify a reference one.
- Treatment adherence only for one of the two conditions (D2T or depression).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Telephone Intervention Group
Nurse-led, telephone-based, and psychoeducational intervention, centered on motivational interviewing and cognitive behavioural therapy for adherence and depression.
|
Nurse-led, telephone-based, and psychoeducational intervention centered on motivational interviewing and cognitive behavioral therapy for adherence and depression.
|
NO_INTERVENTION: Control group
Control group with treatment as usual (TAU).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes control measured by Glycosylated Haemoglobin
Time Frame: Baseline
|
In the Intervention and control group
|
Baseline
|
Diabetes control measured by Glycosylated Haemoglobin
Time Frame: 6-month follow-up
|
In the Intervention and control group
|
6-month follow-up
|
Diabetes control measured by Glycosylated Haemoglobin
Time Frame: 12-month follow-up
|
In the Intervention and Control group
|
12-month follow-up
|
Diabetes control measured by Glycosylated Haemoglobin
Time Frame: 18-month follow-up
|
In the Intervention and Control group
|
18-month follow-up
|
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline
|
In the Intervention and Control group.
The Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression.
PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.
The possible range is 0-27.
|
Baseline
|
Patient Health Questionnaire (PHQ-9)
Time Frame: 6-month follow-up
|
In the Intervention and Control group.
The Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression.
PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.
The possible range is 0-27.
|
6-month follow-up
|
Patient Health Questionnaire (PHQ-9)
Time Frame: 12-month follow-up
|
In the Intervention and Control group.
The Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression.
PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.
The possible range is 0-27.
|
12-month follow-up
|
Patient Health Questionnaire (PHQ-9)
Time Frame: 18-month follow-up
|
In the Intervention and Control group.
The Patient Health Questionnaire (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
PHQ scores ≥ 10 had a sensitivity of 88% and a specificity of 88% for major depression.
PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression.
The possible range is 0-27.
|
18-month follow-up
|
Medication possession ratio (MPR)
Time Frame: Baseline
|
In the Intervention and Control group.
Medication adherence was assessed using the medication possession ratio (MPR).
It is calculated as the proportion of the number of days with treatment provided during the intended period of treatment, that is, 100 × (days supplied) / 365.
Once TA is computed, a dichotomous variable is created as TA (Yes/No) considering a cut-off ratio of MPR ≥80%.
|
Baseline
|
Medication possession ratio (MPR)
Time Frame: 6-month follow-up
|
In the Intervention and Control group.
Medication adherence was assessed using the medication possession ratio (MPR).
It is calculated as the proportion of the number of days with treatment provided during the intended period of treatment, that is, 100 × (days supplied) / 365.
Once TA is computed, a dichotomous variable is created as TA (Yes/No) considering a cut-off ratio of MPR ≥80%.
|
6-month follow-up
|
Medication possession ratio (MPR)
Time Frame: 12-month follow-up
|
In the Intervention and Control group.
Medication adherence was assessed using the medication possession ratio (MPR).
It is calculated as the proportion of the number of days with treatment provided during the intended period of treatment, that is, 100 × (days supplied) / 365.
Once TA is computed, a dichotomous variable is created as TA (Yes/No) considering a cut-off ratio of MPR ≥80%.
|
12-month follow-up
|
Medication possession ratio (MPR)
Time Frame: 18-month follow-up
|
In the Intervention and Control group.
Medication adherence was assessed using the medication possession ratio (MPR).
It is calculated as the proportion of the number of days with treatment provided during the intended period of treatment, that is, 100 × (days supplied) / 365.
Once TA is computed, a dichotomous variable is created as TA (Yes/No) considering a cut-off ratio of MPR ≥80%.
|
18-month follow-up
|
MBG questionnaire
Time Frame: Baseline
|
In the Intervention and Control group.
The MBG questionnaire includes TA questions related to timely drug intake, diet, PCS visits, physical activity, self-management, and others; prior research showed a Cronbach's alpha of 69% and a total explained variance of 63%.
|
Baseline
|
MBG questionnaire
Time Frame: 6-month follow-up
|
In the Intervention and Control group.
The MBG questionnaire includes TA questions related to timely drug intake, diet, PCS visits, physical activity, self-management, and others; prior research showed a Cronbach's alpha of 69% and a total explained variance of 63%.
|
6-month follow-up
|
MBG questionnaire
Time Frame: 12-month follow-up
|
In the Intervention and Control group.
The MBG questionnaire includes TA questions related to timely drug intake, diet, PCS visits, physical activity, self-management, and others; prior research showed a Cronbach's alpha of 69% and a total explained variance of 63%.
|
12-month follow-up
|
MBG questionnaire
Time Frame: 18-month follow-up
|
In the Intervention and Control group.
The MBG questionnaire includes TA questions related to timely drug intake, diet, PCS visits, physical activity, self-management, and others; prior research showed a Cronbach's alpha of 69% and a total explained variance of 63%.
|
18-month follow-up
|
LDL-Cholesterol
Time Frame: Baseline
|
In the Intervention and Control group.
LDL-C values were registered according to reference values and recommendations from the National Cholesterol Education Program Adult Treatment Panel III (2001): <100 mg/dl optimum, 100-129 mg normal or close to optimal level, 130-159 mg/dl normal-high, 160-189 mg/dl high,> 190 mg/dl very high.
|
Baseline
|
LDL-Cholesterol
Time Frame: 6-month follow-up
|
In the Intervention and Control group.
LDL-C values were registered according to reference values and recommendations from the National Cholesterol Education Program Adult Treatment Panel III (2001): <100 mg/dl optimum, 100-129 mg normal or close to optimal level, 130-159 mg/dl normal-high, 160-189 mg/dl high,> 190 mg/dl very high.
|
6-month follow-up
|
LDL-Cholesterol
Time Frame: 12-month follow-up
|
In the Intervention and Control group.
LDL-C values were registered according to reference values and recommendations from the National Cholesterol Education Program Adult Treatment Panel III (2001): <100 mg/dl optimum, 100-129 mg normal or close to optimal level, 130-159 mg/dl normal-high, 160-189 mg/dl high,> 190 mg/dl very high.
|
12-month follow-up
|
LDL-Cholesterol
Time Frame: 18-month follow-up
|
In the Intervention and Control group.
LDL-C values were registered according to reference values and recommendations from the National Cholesterol Education Program Adult Treatment Panel III (2001): <100 mg/dl optimum, 100-129 mg normal or close to optimal level, 130-159 mg/dl normal-high, 160-189 mg/dl high,> 190 mg/dl very high.
|
18-month follow-up
|
Diabetes Distress Scale (DDS)
Time Frame: Baseline
|
In the Intervention and Control group.
Four main domains can be identified in DDS: emotional burden, physician-related distress, regimen-related distress, and interpersonal distress, as well as obtaining a total score.
Previous analyses identified that DDS had good sensitivity (95%) and specificity (85%), and was considered a reliable (α = 0.93) instrument for clinical practice and research (Polonsky et al., 2005), and has been validated in Spanish language (Ortiz et al., 2013).
|
Baseline
|
Diabetes Distress Scale (DDS)
Time Frame: 6-month follow-up
|
In the Intervention and Control group.
Four main domains can be identified in DDS: emotional burden, physician-related distress, regimen-related distress, and interpersonal distress, as well as obtaining a total score.
Previous analyses identified that DDS had good sensitivity (95%) and specificity (85%), and was considered a reliable (α = 0.93) instrument for clinical practice and research (Polonsky et al., 2005), and has been validated in Spanish language (Ortiz et al., 2013).
|
6-month follow-up
|
Diabetes Distress Scale (DDS)
Time Frame: 12-month follow-up
|
In the Intervention and Control group.
Four main domains can be identified in DDS: emotional burden, physician-related distress, regimen-related distress, and interpersonal distress, as well as obtaining a total score.
Previous analyses identified that DDS had good sensitivity (95%) and specificity (85%), and was considered a reliable (α = 0.93) instrument for clinical practice and research (Polonsky et al., 2005), and has been validated in Spanish language (Ortiz et al., 2013).
|
12-month follow-up
|
Diabetes Distress Scale (DDS)
Time Frame: 18-month follow-up
|
In the Intervention and Control group.
Four main domains can be identified in DDS: emotional burden, physician-related distress, regimen-related distress, and interpersonal distress, as well as obtaining a total score.
Previous analyses identified that DDS had good sensitivity (95%) and specificity (85%), and was considered a reliable (α = 0.93) instrument for clinical practice and research (Polonsky et al., 2005), and has been validated in Spanish language (Ortiz et al., 2013).
|
18-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time Frame: Baseline
|
In the Intervention group and the Control group
|
Baseline
|
Blood pressure
Time Frame: Baseline
|
Blood pressure was measured according to the Spanish Heart Society (Moliner de la Puente et al., 2008), which is based on the National Institute for Health and Clinical Excellence guidelines (NICE, 2011).
|
Baseline
|
Blood pressure
Time Frame: 6-month follow-up
|
Blood pressure was measured according to the Spanish Heart Society (Moliner de la Puente et al., 2008), which is based on the National Institute for Health and Clinical Excellence guidelines (NICE, 2011).
|
6-month follow-up
|
Blood pressure
Time Frame: 12-month follow-up
|
Blood pressure was measured according to the Spanish Heart Society (Moliner de la Puente et al., 2008), which is based on the National Institute for Health and Clinical Excellence guidelines (NICE, 2011).
|
12-month follow-up
|
Blood pressure
Time Frame: 18-month follow-up
|
Blood pressure was measured according to the Spanish Heart Society (Moliner de la Puente et al., 2008), which is based on the National Institute for Health and Clinical Excellence guidelines (NICE, 2011).
|
18-month follow-up
|
Body mass index (BMI)
Time Frame: Baseline
|
Body mass index (BMI) calculated as weight in kilograms divided by height height in square meters.
In patients who are overweight or obese, a moderate reduction in body weight (5-10% of weight) is associated with improved insulin sensitivity, better glycemic control, reduced triglycerides and increased serum c-HDL.
|
Baseline
|
Body mass index (BMI)
Time Frame: 6-month follow-up
|
Body mass index (BMI) calculated as weight in kilograms divided by height height in square meters.
In patients who are overweight or obese, a moderate reduction in body weight (5-10% of weight) is associated with improved insulin sensitivity, better glycemic control, reduced triglycerides and increased serum c-HDL.
|
6-month follow-up
|
Body mass index (BMI)
Time Frame: 12-month follow-up
|
Body mass index (BMI) calculated as weight in kilograms divided by height height in square meters.
In patients who are overweight or obese, a moderate reduction in body weight (5-10% of weight) is associated with improved insulin sensitivity, better glycemic control, reduced triglycerides and increased serum c-HDL.
|
12-month follow-up
|
Body mass index (BMI)
Time Frame: 18-month follow-up
|
Body mass index (BMI) calculated as weight in kilograms divided by height height in square meters.
In patients who are overweight or obese, a moderate reduction in body weight (5-10% of weight) is associated with improved insulin sensitivity, better glycemic control, reduced triglycerides and increased serum c-HDL.
|
18-month follow-up
|
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
Time Frame: Baseline
|
The research nurse will record her qualitative and quantitative evaluation on how she thinks the patient is responding to treatment adherence and any detail of both diabetes and depression management.
This evaluation will include a quantitative measure containing a 1-5 scale and a qualitative recording.
This assessment will serve as a reference to compare with the patients' responses.
|
Baseline
|
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
Time Frame: 6-month follow-up
|
The research nurse will record her qualitative and quantitative evaluation on how she thinks the patient is responding to treatment adherence and any detail of both diabetes and depression management.
This evaluation will include a quantitative measure containing a 1-5 scale and a qualitative recording.
This assessment will serve as a reference to compare with the patients' responses.
|
6-month follow-up
|
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
Time Frame: 12-month follow-up
|
The research nurse will record her qualitative and quantitative evaluation on how she thinks the patient is responding to treatment adherence and any detail of both diabetes and depression management.
This evaluation will include a quantitative measure containing a 1-5 scale and a qualitative recording.
This assessment will serve as a reference to compare with the patients' responses.
|
12-month follow-up
|
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
Time Frame: 18-month follow-up
|
The research nurse will record her qualitative and quantitative evaluation on how she thinks the patient is responding to treatment adherence and any detail of both diabetes and depression management.
This evaluation will include a quantitative measure containing a 1-5 scale and a qualitative recording.
This assessment will serve as a reference to compare with the patients' responses.
|
18-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: María-Luisa Lozano-del-Hoyo, MSc, Universidad de Zaragoza
- Principal Investigator: María-Teresa Fernández-Rodrigo, PhD, Universidad de Zaragoza
- Principal Investigator: Juan F Roy, PhD, Camilo Jose Cela University
Publications and helpful links
General Publications
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- Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
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- Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care. 2001 Jun;24(6):1069-78. doi: 10.2337/diacare.24.6.1069.
- Ho PM, Rumsfeld JS, Masoudi FA, McClure DL, Plomondon ME, Steiner JF, Magid DJ. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006 Sep 25;166(17):1836-41. doi: 10.1001/archinte.166.17.1836.
- Agámez Paternina, A.P., Hernández Riera, R., Cervera Estrada, L., Rodríguez García, Y., 2008. Factores relacionados con la no adherencia al tratamiento antihipertensivo. Revista Archivo Médico de Camagüey, 12(5). ISSN 1025-0255.
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- Al-Hayek AA, Robert AA, Alzaid AA, Nusair HM, Zbaidi NS, Al-Eithan MH, Sam AE. Association between diabetes self-care, medication adherence, anxiety, depression, and glycemic control in type 2 diabetes. Saudi Med J. 2012 Jun;33(6):681-3. No abstract available.
- Ali S, Stone M, Skinner TC, Robertson N, Davies M, Khunti K. The association between depression and health-related quality of life in people with type 2 diabetes: a systematic literature review. Diabetes Metab Res Rev. 2010 Feb;26(2):75-89. doi: 10.1002/dmrr.1065.
- American Diabetes Association. Standards of Medical Care in Diabetes-2015. Diabetes Care 2015;38(Suppl. 1), S1-S94. https://doi.org/10.2337/diaclin.33.2.97
- Andrade SE, Kahler KH, Frech F, Chan KA. Methods for evaluation of medication adherence and persistence using automated databases. Pharmacoepidemiol Drug Saf. 2006 Aug;15(8):565-74; discussion 575-7. doi: 10.1002/pds.1230.
- Asche C, LaFleur J, Conner C. A review of diabetes treatment adherence and the association with clinical and economic outcomes. Clin Ther. 2011 Jan;33(1):74-109. doi: 10.1016/j.clinthera.2011.01.019.
- Baader, M., Tomas, Molina, F., José Luis, Venezian, B., Silvia, Rojas, C., Carmen, Farías, S., Renata, Fierro-Freixenet, Carlos, Backenstrass, Mathias, Mundt, Christoph., 2012. Validación y utilidad de la encuesta PHQ-9 (Patient Health Questionnaire) en el diagnóstico de depresión en pacientes usuarios de atención primaria en Chile. Rev. Chil. de neuro-psiquiatr. 50(1), 10-22. https://dx.doi.org/10.4067/S0717-92272012000100002
- Campayo A, de Jonge P, Roy JF, Saz P, de la Camara C, Quintanilla MA, Marcos G, Santabarbara J, Lobo A; ZARADEMP Project. Depressive disorder and incident diabetes mellitus: the effect of characteristics of depression. Am J Psychiatry. 2010 May;167(5):580-8. doi: 10.1176/appi.ajp.2009.09010038. Epub 2010 Feb 1.
- Catapano AL, Reiner Z, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman M, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; European Society of Cardiology (ESC); European Atherosclerosis Society (EAS). ESC/EAS Guidelines for the management of dyslipidaemias The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Atherosclerosis. 2011 Jul;217(1):3-46. doi: 10.1016/j.atherosclerosis.2011.06.028. No abstract available.
- Chireh B, D'Arcy C. Shared and unique risk factors for depression and diabetes mellitus in a longitudinal study, implications for prevention: an analysis of a longitudinal population sample aged ⩾45 years. Ther Adv Endocrinol Metab. 2019 Jul 25;10:2042018819865828. doi: 10.1177/2042018819865828. eCollection 2019.
- De-la-Camara, C.; Gracia-Garcia, P.; Roy, J. F.; et al, 2010. Influence of gender on baseline characteristics of depression and future risk for incident stroke an elderly population: Results from the ZARADEMP project. Journal of Psychosomatic Research, 68(6), 618-618. Web of Science (WOS): 000278468200047. HTTPS://DOI.ORG/10.1111/cns.12339
- de Jonge P, Roy JF, Saz P, Marcos G, Lobo A; ZARADEMP Investigators. Prevalent and incident depression in community-dwelling elderly persons with diabetes mellitus: results from the ZARADEMP project. Diabetologia. 2006 Nov;49(11):2627-33. doi: 10.1007/s00125-006-0442-x. Epub 2006 Sep 21.
- Delahanty LM, Grant RW, Wittenberg E, Bosch JL, Wexler DJ, Cagliero E, Meigs JB. Association of diabetes-related emotional distress with diabetes treatment in primary care patients with Type 2 diabetes. Diabet Med. 2007 Jan;24(1):48-54. doi: 10.1111/j.1464-5491.2007.02028.x.
- Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021.
- DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004 Mar;42(3):200-9. doi: 10.1097/01.mlr.0000114908.90348.f9.
- Egede LE, Nietert PJ, Zheng D. Depression and all-cause and coronary heart disease mortality among adults with and without diabetes. Diabetes Care. 2005 Jun;28(6):1339-45. doi: 10.2337/diacare.28.6.1339.
- Fisher L, Glasgow RE, Strycker LA. The relationship between diabetes distress and clinical depression with glycemic control among patients with type 2 diabetes. Diabetes Care. 2010 May;33(5):1034-6. doi: 10.2337/dc09-2175. Epub 2010 Feb 11.
- Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6.
- Fisher L, Mullan JT, Arean P, Glasgow RE, Hessler D, Masharani U. Diabetes distress but not clinical depression or depressive symptoms is associated with glycemic control in both cross-sectional and longitudinal analyses. Diabetes Care. 2010 Jan;33(1):23-8. doi: 10.2337/dc09-1238. Epub 2009 Oct 16.
- Gonzalez JS, Peyrot M, McCarl LA, Collins EM, Serpa L, Mimiaga MJ, Safren SA. Depression and diabetes treatment nonadherence: a meta-analysis. Diabetes Care. 2008 Dec;31(12):2398-403. doi: 10.2337/dc08-1341.
- Gonzalez JS, Tanenbaum ML, Commissariat PV. Psychosocial factors in medication adherence and diabetes self-management: Implications for research and practice. Am Psychol. 2016 Oct;71(7):539-551. doi: 10.1037/a0040388.
- Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, Moher D; , on behalf of the CONSORT-SPI Group. CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials. Trials. 2018 Jul 31;19(1):406. doi: 10.1186/s13063-018-2735-z.
- Grossman A, Grossman E. Blood pressure control in type 2 diabetic patients. Cardiovasc Diabetol. 2017 Jan 6;16(1):3. doi: 10.1186/s12933-016-0485-3.
- Expert Dyslipidemia Panel; Grundy SM. An International Atherosclerosis Society Position Paper: global recommendations for the management of dyslipidemia. J Clin Lipidol. 2013 Nov-Dec;7(6):561-5. doi: 10.1016/j.jacl.2013.10.001. Epub 2013 Oct 22.
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