Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Adherence Intervention in Patients With Type 2 Diabetes and Comorbid Depression (TELE-DD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097483
Recruitment Status : Active, not recruiting
First Posted : September 20, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Universidad de Zaragoza
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria Aragón

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Depression Behavioral: Telephone Intervention Group Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Primary Care specialist will be blind, but the telephonic intervention research nurses will not. For ethical and practical reasons, the trial will be unmasked, and participants will not be blind to the treatment condition once allocated.
Primary Purpose: Treatment
Official Title: The TELE-DD Project: a Nurse-led Randomised Controlled Trial on Treatment Adherence in Patients With Type 2 Diabetes and Comorbid Depression
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: Telephone Intervention Group
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).



Primary Outcome Measures :
  1. Diabetes control measured by Glycosylated Haemoglobin [ Time Frame: Baseline ]
    In the Intervention and control group

  2. Diabetes control measured by Glycosylated Haemoglobin [ Time Frame: 6-month follow-up ]
    In the Intervention and control group

  3. Diabetes control measured by Glycosylated Haemoglobin [ Time Frame: 12-month follow-up ]
    In the Intervention and Control group

  4. Diabetes control measured by Glycosylated Haemoglobin [ Time Frame: 18-month follow-up ]
    In the Intervention and Control group

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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%.

  10. 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%.

  11. 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. 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%.

  13. 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%.

  14. 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%.

  15. 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%.

  16. 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%.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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).

  22. 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).

  23. 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).

  24. 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).


Secondary Outcome Measures :
  1. Sociodemographic data Gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
    In the Intervention group and the Control group

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097483


Sponsors and Collaborators
Instituto de Investigación Sanitaria Aragón
Universidad de Zaragoza
Investigators
Layout table for investigator information
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:
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.
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
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
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
Haynes RB. Determinants of compliance: The disease and the mechanics of treatment. Compliance in health care. Baltimore, MD, Johns Hopkins University Press, 1979. https://doi.org/10.1016/S0197-0070(84)80012-1
International Diabetes Federation, 2017. IDF Diabetes Atlas (8th edition). International Diabetes Federation. https://www.idf.org/e-library/epidemiology-research/diabetes-atlas.html (accessed 20 April 2019).
Iverson, C., Christiansen, S., Flanigan, A., et al., 2007. AMA Manual of Style. 10th ed. New York, Oxford University Press, pp. 416-417.
Lingam R, Scott J. Treatment non-adherence in affective disorders. Acta Psychiatr Scand. 2002 Mar;105(3):164-72. Review. PubMed PMID: 11939969. https://doi.org/10.5498/wjp.v6.i4.399
Martínez, J.W., Villa Perea, J.A., Jaramillo, J., Quintero, A.M., 2011. Validación del cuestionario de adherencia al tratamiento antihipertensivo Martín Bayarré Grau. Revista Médica de Risaralda, 17(2), 101-105. HTTPS://DOI.ORG/http://dx.doi.org/10.22517/25395203.7595
Martín Alfonso, Libertad, Bayarre Vea, Héctor D, Grau Ábalo, Jorge A., 2008. Validación del cuestionario MBG (Martín-Bayarre-Grau) para evaluar la adherencia terapéutica en hipertensión arterial. Revista Cubana de Salud Pública, 34(1). [citado 2019-08-11]. ISSN 0864-3466. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0864-34662008000100012&lng=es&nrm=iso
Miller WR, Rollnick S. Motivational interviewing: helping people change. 3rd edn. New York, NY: Guilford Press, 2013.
Moliner de la Puente, J.R, Domínguez Sardiña, M, González Paradela, C, Castiñeira Pérez, C, Cespo Sabarís, J.J, Chayan Zas, L, Gonzálvez Rey, J, Pérez García, M, Ríos Rey, M.T, Rodríguez Fernández, M., 2008. Hipertensión arterial in: Guías para la consulta de Atención Primaria. (3a ed.). A Coruña: Casiterides SL.
National Clinical Guideline Centre (UK). Hypertension: The Clinical Management of Primary Hypertension in Adults: Update of Clinical Guidelines 18 and 34 [Internet]. London: Royal College of Physicians (UK); 2011 Aug. (NICE Clinical Guidelines, No. 127.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK83274/
Ortiz, M. S., Baeza-Rivera, M. J., & Myers, H. F. (2013). Propiedades psicométricas de la escala de estrés para diabéticos en una muestra de pacientes diabéticos tipo II chilenos. Terapia psicológica, 31(3), 281-286. http://dx.doi.org/10.4067/S0718-48082013000300002
Roy, J. F.; De la Camara, C.; Saz, P.; et al., 2008. Psychosomatic implications in the longitudinal study of late-life depression in the community: The ZARADEMP Project. Journal of Psychosomatic Research, 64(6), 671-671. Web of Science (WOS): 000256455300125
Roy, JF; Saz, P; Lobo, A. A longitudinal study of old-age depression in the community: multivariate modelling of psychopathological symptoms to predict incident depression, 2008. Journal of Psychosomatic Research, 59(1), 45-46. Web of Science (WOS): 000232433800096
Roy, J. F.; Santabarbara, J.; De-la-Camara, C.; et al, 2010. Cardiovascular burden and long-term risk of first-ever depression: Implications for the vascular depression hypothesis from a population-based study. Journal of Psychosomatic Research, 68(6): 661-661. Web of Science (WOS): 000278468200154
Santabarbara, J.; Roy, J. F.; De-la-Camara, C.; et al, 2010. History of stroke, incident depressive disorder and competing risk of death. Journal of Psychosomatic Research, 68(6), 662-663. Web of Science (WOS): 000278468200158
World Health Organization, 2019. Body Mass Index. Extracted from: http://www.euro.who.int/en/health-topics/disease-prevention/nutrition/a-healthy-lifestyle/body-mass-index-bmi

Layout table for additonal information
Responsible Party: Instituto de Investigación Sanitaria Aragón
ClinicalTrials.gov Identifier: NCT04097483     History of Changes
Other Study ID Numbers: TELE-DD
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Sanitaria Aragón:
Comorbidity
Depression
Type 2 Diabetes
Primary Health Care
Randomized-Controlled Trial
Treatment Adherence
Telephone-Based Intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Depression
Depressive Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders