Web-Based Collaborative Care for Patients With Diabetes and Depression (WBCC)

November 14, 2013 updated by: Tao Hong, Beijing Anzhen Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huang Zhenru
  • Phone Number: 13811558293

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010
        • Beijing Anzhen Hospital
        • Sub-Investigator:
          • Huang Zhenru

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: web-based,CBT,MI,TTM, outpatient
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.
Device: web-based collaborative care

Firstly ,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.

Secondly, usual diabetes outpatient care for 6 months.

Other Names:
  • multidisciplinary care
Other: wait-list
Firstly ,usual diabetes outpatient care for 6 months. Secondly,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
Other Names:
  • usual diabetes outpatient care
Behavioral: usual diabetes outpatient care
OTHER: waitlist, usual diabetes outpatient
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.
Device: web-based collaborative care

Firstly ,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.

Secondly, usual diabetes outpatient care for 6 months.

Other Names:
  • multidisciplinary care
Other: wait-list
Firstly ,usual diabetes outpatient care for 6 months. Secondly,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
Other Names:
  • usual diabetes outpatient care
Behavioral: usual diabetes outpatient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire-9 items (PHQ-9) score
Time Frame: 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.
baseline , 3-month, 6-month,9-month, 12-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in biochemical index
Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month
We will compare changes in hemoglobin A1c, blood glucose,blood lipids, and blood pressure levels between the immediate intervention group and the wait-list control group over time.Improvement is defined as 10% improvement over baseline.
Baseline, 3-month, 6-month, 9-month, 12-month
Chang in quality of life (EuroQol-5D)score
Time Frame: baseline, 3-month, 6-month,9-month, 12-month
The health-related quality of patients' life was rated with use of the quality-of-life EuroQol-5 Dimensions (EQ-5D)index.
baseline, 3-month, 6-month,9-month, 12-month
Change in Diabetes-specific stress
Time Frame: Baseline, 3-month, 6-month,9-month, 12-month
Measured by Problem Areas In Diabetes 5-level questionnaire (PAID-5).
Baseline, 3-month, 6-month,9-month, 12-month
Change in Health behaviours
Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month
We will assess of smoking behaviours,alcohol consumption, physical activity,and medication taking.
Baseline, 3-month, 6-month, 9-month, 12-month
Change in general self-efficacy
Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month
General self-efficacy is measured by a widely used parsimonious ten-item scale called 'General Self-Efficacy Scale(GSES)',which was developed for use in several cultures.
Baseline, 3-month, 6-month, 9-month, 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Collaborators

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Tao Hong, Beijing Anzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

April 1, 2017

Study Registration Dates

First Submitted

November 9, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (ESTIMATE)

November 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WBCCFPWDAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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