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临床试验/NCT01985711
NCT01985711Unknown不适用

Effects of a Web-Based Collaborative Care Management System (WBCCMS) on Psychosocial Outcomes and Biochemical Outcomes Among Patients With Diabetes and Depression

Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Change in Patient Health Questionnaire-9 items (PHQ-9) score

研究概览

简要总结

The goal of this proposal is to integrate depression services and diabetes care methods into a web-based collaborative care system so that a single program can assist patients with diabetes and co-morbid depression. The investigators hypothesized that the effect of the intervention program on (a) decreasing depressive symptomatology; (b) improving biomedical outcomes (e.g., blood lipid profiles,blood glucose, glycosylated hemoglobin, and blood pressure). (c) Increasing healthful behavior (medicine compliance, physical activity, diabetic diet);(d)decreasing unhealthful behavior( sedentary activities, smoking, alcohol addiction); (e) improving quality of life.

详细描述

Recent study shows that the overall prevalence of diabetes was estimated to be 11.6% (95% confidence interval, 11.3%-11.8%) in the Chinese adult population[1]. Depression is a common comorbidities in patients with diabetes with prevalence rates more than 30%[2, 3]. Co-morbid depression portends worse health outcomes (such as glycemic control, medication adherence, quality of life, physical activity, and blood pressure control,diabetic complication) and increases health care costs[4-6]. But the rate of diabetes-depression recognition and treatment is low. Collaborative primary care model, which involves a multidisciplinary health care team guiding patient-centered care , has been tested in the US and showed a significant reduction of depressive symptoms, improved diabetes care and patient-reported outcomes, and saved money. We aim to developing a web-based collaborative care system and compare the effectiveness of this new collaborative care model with usual diabetes outpatient care for patients with type 2 diabetes and depression in China.

The web-based collaborative care system integrates usual management plan of diabetes and established theories for treating depression and diabetes specific behaviors or affective disorders. Diabetes management plan consists of a meal plan, exercise guidance, oral medications or insulin guidance, health education, supervision and regular blood glucose monitoring. Three main established theories of psychology as follows: 1) Cognitive Behavioral Therapy (CBT); 2) Transtheoretical Model(TTM)of Behavior Change[7]; and 3) Motivational interviewing(MI)[8]. Cognitive behavioral therapy helps people learn to change inappropriate or negative thought patterns and behaviors associated with the illness. Web-based CBT is generally viewed as a very effective form of psychotherapy for treating depression[9-12], which is also effective to manage diabetic stress[13]. Transtheoretical Model of Behavior Change and Motivational interviewing are both evidence-based behavior change techniques to improve diabetes and depression associated healthy behavior (such as taking medicine, physical activity, diabetic diet, drug therapy compliance) and to decrease unhealthy behavior(such as sedentary activities, smoking, alcohol addiction).The intervention will be conducted in a safety-net health system primary care setting.

A randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of culturally adapted diabetes and depression collaborative treatment for reducing depressive symptoms, activating diabetes healthy behaviors, decreasing unhealthy behaviors and improving adherence to diabetes self-care regimens in Chinese with depression and diabetes. Participation in this study will last 12 months. All participants will firstly undergo baseline assessments that will include a 40-minute interview about personal health and feelings. Eligible participants will then be assigned randomly to receive either web-based collaborative care or wait-list. Participants in web-based collaborative care group will receive 24 weekly 40-minute web-based Cognitive Behavioral Therapy (CBT) sessions, undergo structured Transtheoretical Model of Behavior Change or Motivational interviewing to set up proper life-style and healthy behavior to improve their live quality,conducted on the web. Besides, they will receive usual diabetes outpatient care and web-based diabetes care. Participants assigned to the wait-list group will be given usual diabetes outpatient service (diabetic medication guidance and appointment to see doctor as routine, without specific anti-depression therapy). After 6 months, they will receive web-based collaborative care for 6 months too. All participants receiving web-based collaborative care management will also receive supportive patient navigation services and maintenance/relapse telephone monitoring, their assistants (family member; online systems nurse, psychiatrists and endocrinologist) monitor and help them change their behaviors. All participants will undergo follow-up on-site interviews about their status at months 3, 6, 9 and12.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of Type 2 Diabetes
  • 18 years and older
  • be able to surf the internet at least once per week
  • willing to give informed consent
  • Score >=10 on the PHQ-9

排除标准

  • inability to give informed consent
  • Already receiving antidepressant treatment(medicine,CBT,et.)
  • unwillingness or inability to use the web-based Collaborative Care System.
  • Severe and/or terminal physical illness
  • Pregnant or breastfeeding
  • severe psychiatric disorders (psychotic disorder, major depression and so on) or suicidal tendencies
  • Likely to have difficulty completing the forms and questionnaires

研究组 & 干预措施

waitlist, usual diabetes outpatient

Other

Participants assigned to the wait-list group will be given usual diabetes outpatient service (diabetic medication guidance and appointment to see doctor as routine, without specific anti-depression therapy). After 6 months, they will receive web-based collaborative care for 6 months too.

干预措施: wait-list (Other)

waitlist, usual diabetes outpatient

Other

Participants assigned to the wait-list group will be given usual diabetes outpatient service (diabetic medication guidance and appointment to see doctor as routine, without specific anti-depression therapy). After 6 months, they will receive web-based collaborative care for 6 months too.

干预措施: usual diabetes outpatient care (Behavioral)

web-based,CBT,MI,TTM, outpatient

Experimental

Participants in web-based collaborative care group will receive 24 weekly 40-minute web-based Cognitive Behavioral Therapy (CBT) sessions, undergo structured Transtheoretical Model of Behavior Change or Motivational interviewing to set up proper life-style and healthy behavior to improve their live quality,conducted on the web. Besides, they will receive usual diabetes outpatient care and web-based diabetes care.

干预措施: web-based collaborative care (Device)

web-based,CBT,MI,TTM, outpatient

Experimental

Participants in web-based collaborative care group will receive 24 weekly 40-minute web-based Cognitive Behavioral Therapy (CBT) sessions, undergo structured Transtheoretical Model of Behavior Change or Motivational interviewing to set up proper life-style and healthy behavior to improve their live quality,conducted on the web. Besides, they will receive usual diabetes outpatient care and web-based diabetes care.

干预措施: wait-list (Other)

web-based,CBT,MI,TTM, outpatient

Experimental

Participants in web-based collaborative care group will receive 24 weekly 40-minute web-based Cognitive Behavioral Therapy (CBT) sessions, undergo structured Transtheoretical Model of Behavior Change or Motivational interviewing to set up proper life-style and healthy behavior to improve their live quality,conducted on the web. Besides, they will receive usual diabetes outpatient care and web-based diabetes care.

干预措施: usual diabetes outpatient care (Behavioral)

waitlist, usual diabetes outpatient

Other

Participants assigned to the wait-list group will be given usual diabetes outpatient service (diabetic medication guidance and appointment to see doctor as routine, without specific anti-depression therapy). After 6 months, they will receive web-based collaborative care for 6 months too.

干预措施: web-based collaborative care (Device)

结局指标

主要结局

Change in Patient Health Questionnaire-9 items (PHQ-9) score

时间窗: baseline , 3-month, 6-month,9-month, 12-month

Depressive symptoms were measured using the nine-item Patient Health Questionnaire (PHQ-9).PHQ-9 scored on a range from 0 to 27, where lower scores represent fewer depressive symptoms.A remission of depression symptoms is indicated with a PHQ-9 score \<10 for a period of three consecutive months.

次要结局

  • Change in Diabetes-specific stress(Baseline, 3-month, 6-month,9-month, 12-month)
  • Change in general self-efficacy(Baseline, 3-month, 6-month, 9-month, 12-month)
  • Chang in quality of life (EuroQol-5D)score(baseline, 3-month, 6-month,9-month, 12-month)
  • Change in biochemical index(Baseline, 3-month, 6-month, 9-month, 12-month)
  • Change in Health behaviours(Baseline, 3-month, 6-month, 9-month, 12-month)

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tao Hong

PHD

Beijing Anzhen Hospital

研究点 (1)

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