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Among patients with diabetes and depression in India, does a 12-month collaborative care intervention that includes nonphysician care coordinators, decision support functions in electronic health records, and specialist case reviews improve depressive symptoms and measures of cardiometabolic health more than usual care at 24 months?
In this randomized clinical trial that included 404 patients at urban clinics in India with poorly controlled diabetes and depression, patients in the collaborative care intervention group, compared with the usual care group, were significantly more likely to achieve the composite outcome of at least a 50% reduction in the 20-item Symptom Checklist Depression Scale score and at least 1 of the following: reduction of at least 0.5 percentage points in hemoglobin A1c, reduction of at least 5 mm Hg in systolic blood pressure, or reduction of at least 10 mg/dL in low-density lipoprotein cholesterol at 24 months (71.6% vs 54.7%).
Among patients with diabetes and depressive symptoms in urban India, a multicomponent collaborative care intervention resulted in statistically significantly greater improvements in a composite measure of depressive symptoms and cardiometabolic indices compared with usual care.
Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented.
To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression.
Design, Setting, and Participants
Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018.
Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months.
Main Outcomes and Measures
The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA1c, 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (≥50% reduction in SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol.
Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0).
Conclusions and Relevance
Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings.
ClinicalTrials.gov Identifier: NCT02022111
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Corresponding Author: Mohammed K. Ali, MD, MSc, MBA, Emory University, 1518 Clifton Rd, CNR Room 7041, Atlanta, GA 30322 (firstname.lastname@example.org).
Accepted for Publication: June 16, 2020.
Author Contributions: Dr Ali and Mr Emmert-Fees had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Ali, Chwastiak, Poongothai, Anjana, Shankar, Sridhar, Kosuri, Rao, Tandon, Narayan, Mohan.
Acquisition, analysis, or interpretation of data: Chwastiak, Emmert-Fees, Patel, Sagar, A. Sosale, B. Sosale, Rao.
Drafting of the manuscript: Ali, Emmert-Fees, Patel, Sridhar, Rao.
Critical revision of the manuscript for important intellectual content: Ali, Chwastiak, Poongothai, Emmert-Fees, Patel, Anjana, Sagar, Shankar, Kosuri, A. Sosale, B. Sosale, Rao, Tandon, Narayan, Mohan.
Statistical analysis: Chwastiak, Emmert-Fees, Patel.
Obtained funding: Ali, Rao, Narayan.
Administrative, technical, or material support: Ali, Chwastiak, Poongothai, Anjana, Sagar, Sridhar, B. Sosale, Rao, Tandon.
Supervision: Ali, Poongothai, Shankar, A. Sosale, B. Sosale, Rao, Tandon, Narayan, Mohan.
Conflict of Interest Disclosures: Dr Ali reported receiving a grant from Merck outside the submitted work. No other disclosures were reported.
Group information: Nonauthor Contributions to data collection and conduct of the trial: Executive committee: Mohammed K. Ali, MD, MSc, MBA; Lydia Chwastiak, MD, MPH; Viswanathan Mohan, MD, PhD, DSc; Subramani Poongothai, PhD; Mark L. Hutcheson, BA. Coordinating center: Subramani Poongothai, PhD; Nandakumar Parthasarathy, BPharm; Mark L. Hutcheson, BA. Data management and analysis team: Karl M. F. Emmert-Fees, MSPH; Shivani A. Patel, MPH, PhD; Jeba Rani, MBA. Development of decision support electronic health record software: Cygnis Media (https://www.cygnismedia.com/), Mark L. Hutcheson, BA; Alysse J. Kowalski, MPH, PhD; Mohammed K. Ali, MD, MSc, MBA. Data and safety monitoring board members: K. M. Prasanna Kumar, MBBS, MD, DM (MS Ramaiah Medical College, Bengaluru, India); Pallab Maulik, MD, PhD, MSc (George Institute for Global Health, Delhi, India); N. Sreekumaran Nair, PhD (Manipal University, Manipal, India); Usha Rani Pingali, MBBS, MD (Nizam's Institute of Medical Sciences, Hyderabad, India). Site Investigators and research staff: PI: Nikhil Tandon, MD, PhD; Co-I(s): Rajesh Khadgawat, MD, DM; Rajesh Sagar, MD; Radhika Tandon, MD; care coordinator(s): Chandni Chopra, MSc; Bhanvi Grover, MSc; outcome assessor(s): Tania Bhardwaj, MSc; Priyanka Rawat, MSc. Recruiter/Screener: Jijo Joseph, DipNurs (All India Institute of Medical Sciences, Delhi); PI: Viswanathan Mohan, MD, PhD, DSc. Co-I(s): Radha Shankar, MD; Ranjit M. Anjana, MD, PhD; Sethuraman Jagdish, MBBS, MMed; Pathasarathy Balasubramanian, MBBS; Selvam Kasthuri, MBBS, DDip; care coordinator(s): Bhavani B. Sundari, MSc; Phebegeniya Stephen, MSc; outcome assessor(s): Kulasegaran Karkuzhali, BSc; Vijayaraghavan Prathibha, MBBS, DO, PhD; Ramachandran Rajalakshmi, MBBS, DO, PhD; recruiter/screener: Viswanathan Kannikan, MSc (Dr Mohan’s Diabetes Specialties Center, Chennai); PI: Aravind R. Sosale, MBBS; Co-I(s): Bhavana Sosale, MD; Pooja Rai, DipPsych; care coordinator(s): Raghavan Karthik, BCom, DipCLS; outcome assessor(s): Rangawamy Geethanjali, BPharm; site manager: Sunita K. Somaiah, MD (Diacon Hospital, Diabetes Care and Research Center, Bangalore); PI: Gumpeny R. Sridhar, MD, DM; Co-I(s): Madhu Kosuri, PhD; care coordinator(s): Aruna Sri Sikha, MA; outcome assessor(s): Venkateswarlu Chiramana, PhD; Gumpeny Lakshmi, MD (Endocrine Diabetes Center, Visakapatnam). US Collaborators: Jurgen Unutzer, MD, MPH, MA; Wayne Katon, MD (deceased) (University of Washington); Leslie Johnson, PhD; Nida I. Shaik, PhD, (Emory University); previous contributions by Neil K. Mehta, PhD (University of Michigan); Sue Ruedebusch, RN, CDE (Kaiser Permanente Washington Health Research Institute); and Paul Ciechanowski, MD, MPH (University of Washington).
Funding/Support: This study was funded by the National Institute of Mental Health (grant R01MH100390).
Role of the Funder/Sponsor: The National Institute of Mental Health had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: The INDEPENDENT Study Group thanks all the participating patients.
Data Sharing Statement: See Supplement 3.
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