INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Collaborators:
University of Washington
Madras Diabetes Research Foundation
All India Institute of Medical Sciences, New Delhi
Endocrine & Diabetes Centre
Information provided by (Responsible Party):
Mohammed K Ali, MBChB, MSc, MBA, Emory University
ClinicalTrials.gov Identifier:
NCT02022111
First received: December 17, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

To provide better care and preventive services for people with both depression and diabetes, the investigators propose to develop and test whether interventions to reduce depressive symptoms can be integrated into routine diabetes clinics in India. The investigators will gather feedback from patients in India through focus group discussions and individual interviews so they can culturally-adapt a model of combined depression and diabetes care. The investigators will then evaluate the effectiveness and costs of this care model in a trial at three diabetes clinics in India. It is expected that results from this study can guide how to incorporate mental health care into routine diabetes clinics in low-resource settings.


Condition Intervention
Diabetes
Depression
Cardiovascular Risk Factor
Behavioral: Patient Education and Behavioral Activation
Behavioral: Supporting Self-Care (care coordinators)
Other: Psychiatrist and Diabetologist Reviews
Other: Decision-support Electronic Health Record System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Combined improvement of depressive symptoms and CVD risk factors [ Time Frame: 24-months ] [ Designated as safety issue: No ]
    The sustained (24-month) difference in the proportion of trial participants in each arm achieving combined depression and CVD risk factor improvements (≥50% reduction in SCL-20 score AND ≥1 of: ≥0.5% reduction in HbA1c, ≥5mmHg reduction in systolic blood pressure (SBP), or ≥10mg/dl reduction LDL-c)


Secondary Outcome Measures:
  • Measures of "common effect" i.e. whether the intervention had a similar beneficial effect on all four main targets (SCL-20, HbA1c, SBP, LDL-c) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Proportion of participants achieving all 3 CVD risk factor targets in the two groups [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Mean changes in each of the four main targets (SCL-20 score, HbA1c, SBP, LDL-c) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Proportion of participants achieving treatment targets or significant reductions in individual risk factors [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Individual risk factors: depression control [≥50% reduction in SCL-20]; glycemic control [HbA1c≤7.0% or ≥0.5% reduction); BP control [SBP≤130mmHg or ≥5mmHg reduction]; lipid control [LDL≤100 mg/dl or ≥10mg/dl reduction]

  • Mean treatment satisfaction scores [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Mean health expenditures (direct medical costs) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Mean quality of life scores [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Mean utility scores [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Cost utility [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: October 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention Program of Care
  1. Patient Education and Behavioral Activation by a Care Coordinator;
  2. Supporting Self-Care;
  3. Psychiatrist and Diabetologist Reviews; and
  4. Decision-support Electronic Health Record System
Behavioral: Patient Education and Behavioral Activation
To stimulate and motivate sustained, effective self-care, patient education materials and behavioral activation techniques that are adapted for the Indian population will be used by care coordinators. Behavioral activation strategies are brief, structured psychological interventions that are based on extensive theoretical and clinical literature, can be delivered by non-specialist providers, can be combined with antidepressant medications, and emphasize reinforcing behaviors to produce improvements in thoughts, mood, and quality of life.
Behavioral: Supporting Self-Care (care coordinators)
Care coordinators will: (a) meet with intervention arm patients and collaboratively set treatment goals; (b) provide verbal education regarding diabetes and depression self-care ;(c) will use motivational interviewing and self-efficacy enhancement strategies to promote monitoring of depressive symptoms, glucose, BP; (d) will proactively follow-up to externally monitor depression symptoms and CVD indicators; (e) will enter updated patient indicators into decision-support electronic health record and utilize software outputs to prioritize patients for review; (g) will convene case review meetings with supervising physicians; and (h) will communicate physician-recommended treatment changes to patients and their routine providers.
Other: Psychiatrist and Diabetologist Reviews
A senior psychiatrist and endocrinologist/diabetologist will be involved in weekly offline (patients do not attend) case review meetings with care coordinators. Case review meetings will be structured: the decision-support electronic health record will help prioritize cases that are new (within 3 weeks of randomization); have moderate/severe depression symptoms (based on Patient Health Questionnaire (PHQ)-9) ≥6 weeks after most recent treatment changes, or continued poor HbA1c, home glucose, BP, or LDL-c control in past 4 weeks; or have not been reviewed for 3 months. Based on patient indicators and current therapies, physicians will recommend treatment changes (initiation, increases, or simplification of medication regimens) which will be communicated by care coordinators to patients (who can access prescription changes at local pharmacies) and their usual care providers.
Other: Decision-support Electronic Health Record System
The decision-support electronic health record will store patient indicators entered by the Nurse Case Managers (NCM) and provide diabetes and depression care prompts based on an evidence-based treatment algorithm developed from recommended guidelines for control of diabetes and depression, Indian formularies, and TeamCare investigators. The decision-supported electronic health record (DS-EHR) will prioritize patients (new; poorly-controlled; or well-controlled but not reviewed ≥3 months) for case review meetings and promote accountability (physicians must justify rejecting electronic care prompts).
Placebo Comparator: Control Arm
Participants randomized to the control arm will receive the existing standard care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The physicians treating the control arm will also be provided with trainings regarding identification and care for people with depression. The control participants will have no contact with care coordinators and will only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.

Detailed Description:

It has been shown that targeting both depression and diabetes control has important synergistic benefits. Since diabetes patients in India tend to access specialists (government or private) for their diabetes and other health care needs, they at least have a point of contact with the health system which can be leveraged to also reduce depressive symptoms. The investigators aim to assess if interventions for depression can be integrated into routine diabetes care delivery with only modest modifications. The integrated multi-condition (depression and diabetes) intervention model merges experiences from TEAMCare and an ongoing trial of cardiovascular disease (CVD) risk reduction in India (CARRS Trial) and involves: 1. enhancing the role of care coordinators and training them in disease management; 2. integrating 'intelligent' technology; and 3. weekly physician oversight to review poorly-controlled cases and make responsive treatment adjustments. The investigators propose to take this model from research to practice using an implementation sciences approach. The investigators will first gather formative qualitative data and endeavor to make the intervention more patient-centered, develop locally-understandable educational materials, and identify ways to overcome stigma of mental health disorders and facilitate trustful therapeutic relationships between care coordinators and patients and their families. The investigators will then evaluate the effectiveness and cost-effectiveness of the intervention model in a randomized controlled trial.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥35 years
  • Confirmed diagnosis of diabetes (documented glucose tolerance test or 2 venous glucose levels)
  • PHQ-9 score≥10
  • ≥1 poorly-controlled CVD risk factor (either HbA1c≥8.0% or SBP≥140 mmHg or LDL≥130 mg/dl), irrespective of medications used
  • Willingness to consent to randomization.

Exclusion Criteria:

  • The patient reports a "3" on the PHQ-9 questionnaire suicide item (Item No:9) which reflects very high suicide risk or the patient's PHQ-9 score is above 23 indicating severe depression requiring immediate referral
  • Any participant reporting a "2" on the PHQ-9 suicide item (Item No:9) will be reviewed carefully and if considered too high risk, the participant will be excluded from enrollment in the trial and referred for more intensive psychiatric care.
  • Already in psychiatrist's care or using antipsychotic or mood stabilizer medication or diagnosed dementia or bipolar disorder or schizophrenia (based on bipolar and schizophrenia modules of the MINI)
  • Diabetes secondary to uncommon causes (e.g., chronic pancreatitis)
  • Pregnancy or breastfeeding
  • Documented CVD event (MI, stroke) in past 12 months
  • End-stage renal disease awaiting transplant
  • Malignancy or life-threatening disease with death probable in 3 years
  • Alcohol or drug abuse
  • No fixed address or contact details.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022111

Contacts
Contact: Poongothai Subramani, PhD 91-44-4396-8888 poongothai@mdrf.in

Locations
India
Madras Diabetes Research Foundation Not yet recruiting
Chennai, India
Sub-Investigator: Poongothai Subramani, PhD, MSc         
Sub-Investigator: K. M. Venkat Narayan, MD, MSc         
Sub-Investigator: Neil K. Mehta, PhD         
Sub-Investigator: Jurgen Unutzer, MD, MPH         
Sub-Investigator: Deepa Rao, PhD, MA         
Sub-Investigator: Cecilia Margret, PhD, MPH         
Principal Investigator: Nikhil Tandon, MD, PhD         
Principal Investigator: G. R. Sridhar, DM         
Sub-Investigator: Rajesh Sagar, MD         
Sub-Investigator: Paul S. Ciechanowski, MD         
Sponsors and Collaborators
Emory University
University of Washington
Madras Diabetes Research Foundation
All India Institute of Medical Sciences, New Delhi
Endocrine & Diabetes Centre
Investigators
Principal Investigator: Viswanathan Mohan, MD, PhD Dr Mohan's Diabetes Specialities Clinic
Principal Investigator: Mohammed K Ali, MBChB, MSc Emory University
Principal Investigator: Wayne Katon, MD University of Washington
  More Information

Publications:
Responsible Party: Mohammed K Ali, MBChB, MSc, MBA, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02022111     History of Changes
Other Study ID Numbers: IRB00064913, R01MH100390-01
Study First Received: December 17, 2013
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014