Diabetes Mellitus, Type 2TELE-DDNCT04097483

Treatment Adherence Intervention in Patients With Type 2 Diabetes and Comorbid Depression

A study testing Telephone Intervention Group in people with Diabetes Mellitus, Type 2 and Depression, run by Alicia Monreal Bartolomé.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Depression
What is being tested?: Telephone Intervention Group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 428 participants
Where: No sites listed yet
Study dates: Jan 2017to Mar 2020
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

About this study

Official title: 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.

Read the 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.

Conditions: Diabetes Mellitus, Type 2, Depression
Being tested: Telephone Intervention Group
Keywords: Comorbidity, Depression, Type 2 Diabetes, Primary Health Care, Randomized-Controlled Trial, Treatment Adherence, Telephone-Based Intervention
Medical subject headings: Diabetes Mellitus, Type 2, Depression, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telephone Intervention GroupBehavioural
Nurse-led, telephone-based, and psychoeducational intervention centered on motivational interviewing and cognitive behavioral therapy for adherence and depression.

Study groups in NCT04097483
Study group	Role	What they receive
Telephone Intervention Group	Experimental	Nurse-led, telephone-based, and psychoeducational intervention, centered on motivational interviewing and cognitive behavioural therapy for adherence and depression. Receives: Behavioral: Telephone Intervention Group
Control group	No intervention	Control group with treatment as usual (TAU).

What is being measured

The primary outcome is the main question the study is designed to answer.

Diabetes control measured by Glycosylated Haemoglobin
In the Intervention and control group
Measured: Baseline
Diabetes control measured by Glycosylated Haemoglobin
In the Intervention and control group
Measured: 6-month follow-up
Diabetes control measured by Glycosylated Haemoglobin
In the Intervention and Control group
Measured: 12-month follow-up
Diabetes control measured by Glycosylated Haemoglobin
In the Intervention and Control group
Measured: 18-month follow-up
Patient Health Questionnaire (PHQ-9)
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.
Measured: Baseline
Patient Health Questionnaire (PHQ-9)
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.
Measured: 6-month follow-up
Patient Health Questionnaire (PHQ-9)
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.
Measured: 12-month follow-up
Patient Health Questionnaire (PHQ-9)
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.
Measured: 18-month follow-up
Medication possession ratio (MPR)
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%.
Measured: Baseline
Medication possession ratio (MPR)
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%.
Measured: 6-month follow-up
Medication possession ratio (MPR)
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%.
Measured: 12-month follow-up
Medication possession ratio (MPR)
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%.
Measured: 18-month follow-up
MBG questionnaire
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%.
Measured: Baseline
MBG questionnaire
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%.
Measured: 6-month follow-up
MBG questionnaire
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%.
Measured: 12-month follow-up
MBG questionnaire
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%.
Measured: 18-month follow-up
LDL-Cholesterol
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.
Measured: Baseline
LDL-Cholesterol
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.
Measured: 6-month follow-up
LDL-Cholesterol
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.
Measured: 12-month follow-up
LDL-Cholesterol
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.
Measured: 18-month follow-up
Diabetes Distress Scale (DDS)
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).
Measured: Baseline
Diabetes Distress Scale (DDS)
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).
Measured: 6-month follow-up
Diabetes Distress Scale (DDS)
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).
Measured: 12-month follow-up
Diabetes Distress Scale (DDS)
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).
Measured: 18-month follow-up

Secondary outcomes (13)

Sociodemographic data Gender, age, marital status, education, occupation, economical level
In the Intervention group and the Control group
Measured: Baseline
Blood pressure
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).
Measured: Baseline
Blood pressure
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).
Measured: 6-month follow-up
Blood pressure
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).
Measured: 12-month follow-up
Blood pressure
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).
Measured: 18-month follow-up
Body mass index (BMI)
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.
Measured: Baseline
Body mass index (BMI)
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.
Measured: 6-month follow-up
Body mass index (BMI)
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.
Measured: 12-month follow-up
Body mass index (BMI)
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.
Measured: 18-month follow-up
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
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.
Measured: Baseline
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
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.
Measured: 6-month follow-up
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
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.
Measured: 12-month follow-up
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
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.
Measured: 18-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2017Mar 2020

First posted20 Sep 2019
Study startJan 2017
Primary completionDec 2018
Study completionMar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (91)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 428 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04097483
Sponsor's protocol ID: TELE-DD
Acronym: TELE-DD
Status last verified: Feb 2021
First submitted: 16 Sep 2019
Last updated: 16 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
Aikens JE, Piette JD. Diabetic patients' medication underuse, illness outcomes, and beliefs about antihyperglycemic and antihypertensive treatments. Diabetes Care. 2009 Jan;32(1):19-24. doi: 10.2337/dc08-1533. Epub 2008 Oct 13.
PubMed 18852334
Alam R, Sturt J, Lall R, Winkley K. An updated meta-analysis to assess the effectiveness of psychological interventions delivered by psychological specialists and generalist clinicians on glycaemic control and on psychological status. Patient Educ Couns. 2009 Apr;75(1):25-36. doi: 10.1016/j.pec.2008.08.026. Epub 2008 Dec 11.
PubMed 19084368
Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
PubMed 9686693
Alexander GC, Sehgal NL, Moloney RM, Stafford RS. National trends in treatment of type 2 diabetes mellitus, 1994-2007. Arch Intern Med. 2008 Oct 27;168(19):2088-94. doi: 10.1001/archinte.168.19.2088.
PubMed 18955637
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.
PubMed 22729127
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.
PubMed 20186998
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
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.
PubMed 11375373
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.
PubMed 16514590
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.
PubMed 21397776
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.
PubMed 20123914
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.
PubMed 21882396
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.
PubMed 31384422

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The TELE-DD Project: a Nurse-led Randomised Controlled Trial on Treatment Adherence in Patients With Type 2 Diabetes and Comorbid Depression
ClinicalTrials.gov ID: NCT04097483
Acronym / sponsor ID: TELE-DD / TELE-DD
Conditions: Diabetes Mellitus, Type 2, Depression
Keywords: Comorbidity, Depression, Type 2 Diabetes, Primary Health Care, Randomized-Controlled Trial, Treatment Adherence, Telephone-Based Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 428 participants (actual)
Lead sponsor: Alicia Monreal BartoloméUniversity, hospital or other
Collaborators: Universidad de Zaragoza
Study start: Jan 2017 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Mar 2020 (actual)
First posted: 20 Sep 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Telephone Intervention Group	Experimental	Behavioral: Telephone Intervention GroupNurse-led, telephone-based, and psychoeducational intervention, centered on motivational interviewing and cognitive behavioural therapy for adherence and depression.
Control group	No intervention	–Control group with treatment as usual (TAU).

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (6 listed)

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.

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
Telephone Intervention GroupNurse-led, telephone-based, and psychoeducational intervention centered on motivational interviewing and cognitive behavioral therapy for adherence and depression.	Behavioural	Telephone Intervention Group

Primary outcome

Diabetes control measured by Glycosylated Haemoglobin
Time frame: Baseline
In the Intervention and control group
Diabetes control measured by Glycosylated Haemoglobin
Time frame: 6-month follow-up
In the Intervention and control group
Diabetes control measured by Glycosylated Haemoglobin
Time frame: 12-month follow-up
In the Intervention and Control group
Diabetes control measured by Glycosylated Haemoglobin
Time frame: 18-month follow-up
In the Intervention and Control group
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.
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.
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.
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.
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%.
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%.
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%.
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%.
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%.
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%.
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%.
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%.
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.
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.
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.
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.
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).
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).
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).
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).

13 secondary outcomes

Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time frame: Baseline
Blood pressure
Time frame: Baseline
Blood pressure
Time frame: 6-month follow-up
Blood pressure
Time frame: 12-month follow-up
Blood pressure
Time frame: 18-month follow-up
Body mass index (BMI)
Time frame: Baseline
Body mass index (BMI)
Time frame: 6-month follow-up
Body mass index (BMI)
Time frame: 12-month follow-up
Body mass index (BMI)
Time frame: 18-month follow-up
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
Time frame: Baseline
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
Time frame: 6-month follow-up
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
Time frame: 12-month follow-up
Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.
Time frame: 18-month follow-up

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
BackgroundAgámez 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.
Background: PubMed 18852334Aikens JE, Piette JD. Diabetic patients' medication underuse, illness outcomes, and beliefs about antihyperglycemic and antihypertensive treatments. Diabetes Care. 2009 Jan;32(1):19-24. doi: 10.2337/dc08-1533. Epub 2008 Oct 13.
Background: PubMed 19084368Alam R, Sturt J, Lall R, Winkley K. An updated meta-analysis to assess the effectiveness of psychological interventions delivered by psychological specialists and generalist clinicians on glycaemic control and on psychological status. Patient Educ Couns. 2009 Apr;75(1):25-36. doi: 10.1016/j.pec.2008.08.026. Epub 2008 Dec 11.
Background: PubMed 9686693Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
Background: PubMed 18955637Alexander GC, Sehgal NL, Moloney RM, Stafford RS. National trends in treatment of type 2 diabetes mellitus, 1994-2007. Arch Intern Med. 2008 Oct 27;168(19):2088-94. doi: 10.1001/archinte.168.19.2088.
Background: PubMed 22729127Al-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.
Background: PubMed 20186998Ali 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.
BackgroundAmerican 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
Background: PubMed 11375373Anderson 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.
Background: PubMed 16514590Andrade 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.
Background: PubMed 21397776Asche 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.
BackgroundBaader, 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
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.

María-Luisa Lozano-del-Hoyo, MSc principal investigator

Universidad de Zaragoza

María-Teresa Fernández-Rodrigo, PhD principal investigator

Universidad de Zaragoza

Juan F Roy, PhD principal investigator

Camilo Jose Cela University

Questions about this trial

What is this clinical trial studying?

A study testing Telephone Intervention Group in people with Diabetes Mellitus, Type 2 and Depression, run by Alicia Monreal Bartolomé.

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 7 inclusion and 6 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: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Diabetes control measured by Glycosylated Haemoglobin (time frame: Baseline). The study lists 24 primary outcomes in all. 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 NCT04097483, which also lists 91 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 16 Feb 2021.