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

Depression Clinical Trial

— TELE-DD  

Official title:

The TELE-DD Project: a Nurse-led Randomised Controlled Trial on Treatment Adherence in Patients With Type 2 Diabetes and Comorbid Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097483
• Other study ID #: TELE-DD
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: March 2020

Study information

• Verified date: February 2021
• Source: Instituto de Investigación Sanitaria Aragón
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: March 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alicia Monreal Bartolomé	Universidad de Zaragoza

References & Publications (90)

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van Bastelaar KM, Pouwer F, Geelhoed-Duijvestijn PH, Tack CJ, Bazelmans E, Beekman AT, Heine RJ, Snoek FJ. Diabetes-specific emotional distress mediates the association between depressive symptoms and glycaemic control in Type 1 and Type 2 diabetes. Diabet Med. 2010 Jul;27(7):798-803. doi: 10.1111/j.1464-5491.2010.03025.x. — View Citation

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van der Feltz-Cornelis CM, Nuyen J, Stoop C, Chan J, Jacobson AM, Katon W, Snoek F, Sartorius N. Effect of interventions for major depressive disorder and significant depressive symptoms in patients with diabetes mellitus: a systematic review and meta-analysis. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):380-95. doi: 10.1016/j.genhosppsych.2010.03.011. Epub 2010 May 15. Review. Erratum in: Gen Hosp Psychiatry. 2010 Nov-Dec;32(6):645. — View Citation

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Vermeire E, Wens J, Van Royen P, Biot Y, Hearnshaw H, Lindenmeyer A. Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003638. Review. — View Citation

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* Note: There are 90 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes control measured by Glycosylated Haemoglobin	In the Intervention and control group	Baseline
Primary	Diabetes control measured by Glycosylated Haemoglobin	In the Intervention and control group	6-month follow-up
Primary	Diabetes control measured by Glycosylated Haemoglobin	In the Intervention and Control group	12-month follow-up
Primary	Diabetes control measured by Glycosylated Haemoglobin	In the Intervention and Control group	18-month follow-up
Primary	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.	Baseline
Primary	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.	6-month follow-up
Primary	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.	12-month follow-up
Primary	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.	18-month follow-up
Primary	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%.	Baseline
Primary	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%.	6-month follow-up
Primary	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%.	12-month follow-up
Primary	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%.	18-month follow-up
Primary	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%.	Baseline
Primary	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%.	6-month follow-up
Primary	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%.	12-month follow-up
Primary	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%.	18-month follow-up
Primary	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.	Baseline
Primary	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.	6-month follow-up
Primary	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.	12-month follow-up
Primary	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.	18-month follow-up
Primary	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 (a = 0.93) instrument for clinical practice and research (Polonsky et al., 2005), and has been validated in Spanish language (Ortiz et al., 2013).	Baseline
Primary	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 (a = 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
Primary	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 (a = 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
Primary	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 (a = 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	Sociodemographic data Gender, age, marital status, education, occupation, economical level	In the Intervention group and the Control group	Baseline
Secondary	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).	Baseline
Secondary	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).	6-month follow-up
Secondary	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).	12-month follow-up
Secondary	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).	18-month follow-up
Secondary	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.	Baseline
Secondary	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.	6-month follow-up
Secondary	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.	12-month follow-up
Secondary	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.	18-month follow-up
Secondary	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.	Baseline
Secondary	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.	6-month follow-up
Secondary	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.	12-month follow-up
Secondary	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.	18-month follow-up