The TELE-DD Project: a Nurse-led Randomised Controlled Trial on Treatment Adherence in Patients With Type 2 Diabetes and Comorbid Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 428
- 主要终点
- Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult individuals (21+).
- •Concurrent type 2 diabetes (T2D) and depression diagnose registered in the SALUD clinical computerised system before January 1st,
- •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.
排除标准
- •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).
研究组 & 干预措施
Telephone Intervention Group
Nurse-led, telephone-based, and psychoeducational intervention, centered on motivational interviewing and cognitive behavioural therapy for adherence and depression.
干预措施: Telephone Intervention Group (Behavioral)
Control group
Control group with treatment as usual (TAU).
结局指标
主要结局
Patient Health Questionnaire (PHQ-9)
时间窗: 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.
Diabetes Distress Scale (DDS)
时间窗: 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).
Medication possession ratio (MPR)
时间窗: 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%.
Diabetes control measured by Glycosylated Haemoglobin
时间窗: 18-month follow-up
In the Intervention and Control group
MBG questionnaire
时间窗: 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
时间窗: 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 control measured by Glycosylated Haemoglobin
时间窗: Baseline
In the Intervention and control group
Diabetes control measured by Glycosylated Haemoglobin
时间窗: 6-month follow-up
In the Intervention and control group
Diabetes control measured by Glycosylated Haemoglobin
时间窗: 12-month follow-up
In the Intervention and Control group
Patient Health Questionnaire (PHQ-9)
时间窗: 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)
时间窗: 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)
时间窗: 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.
Medication possession ratio (MPR)
时间窗: 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)
时间窗: 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)
时间窗: 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%.
MBG questionnaire
时间窗: 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
时间窗: 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
时间窗: 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%.
LDL-Cholesterol
时间窗: 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
时间窗: 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
时间窗: 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.
Diabetes Distress Scale (DDS)
时间窗: 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)
时间窗: 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)
时间窗: 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).
次要结局
- Body mass index (BMI)(18-month follow-up)
- Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.(18-month follow-up)
- Sociodemographic data Gender, age, marital status, education, occupation, economical level(Baseline)
- Blood pressure(18-month follow-up)
- Blood pressure(Baseline)
- Blood pressure(6-month follow-up)
- Blood pressure(12-month follow-up)
- Body mass index (BMI)(Baseline)
- Body mass index (BMI)(6-month follow-up)
- Body mass index (BMI)(12-month follow-up)
- Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.(Baseline)
- Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.(6-month follow-up)
- Research nurse qualitative and quantitative evaluation about Treatment Adherence and diseases management.(12-month follow-up)
研究者
Alicia Monreal Bartolomé
MS
Instituto de Investigación Sanitaria Aragón