DiabetesINDEPENDENTNCT02022111
INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
A study testing Patient Education and Behavioral Activation, Supporting Self-Care (care coordinators) and Psychiatrist and Diabetologist Reviews in people with Diabetes and Depression, run by Emory University at 4 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetes, Depression, Cardiovascular Risk Factor
- What is being tested?
- Patient Education and Behavioral Activation, Supporting Self-Care (care coordinators) and Psychiatrist and Diabetologist Reviews
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 4 sitesIndia
- Study dates
- Mar 2014to 27 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Diacon Hospital, Diabetes Care and Research Center
Bangalore
Madras Diabetes Research Foundation
Chennai
All India Institute of Medical Sciences
Delhi
Endocrine Diabetes Center
Visakhapatnam
About this study
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 four 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.
Read the 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.
- Conditions
- Diabetes, Depression, Cardiovascular Risk Factor
- Being tested
- Patient Education and Behavioral Activation, Supporting Self-Care (care coordinators), Psychiatrist and Diabetologist Reviews, Decision-support Electronic Health Record System, Standard of Care
- Medical subject headings
- Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Education and Behavioral ActivationBehavioural
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.
Supporting Self-Care (care coordinators)Behavioural
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.
Psychiatrist and Diabetologist ReviewsOther
Senior psychiatrist and endocrinologist/diabetologist will be involved in weekly offline 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 and their usual care providers.
Decision-support Electronic Health Record SystemOther
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).
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Program of Care | Active comparator | 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 Receives: Behavioral: Patient Education and Behavioral Activation; Behavioral: Supporting Self-Care (care coordinators); Other: Psychiatrist and Diabetologist Reviews; Other: Decision-support Electronic Health Record System |
| Control Arm | Placebo comparator | Participants randomized to the control arm will receive the existing standard of 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors
The sustained (24-month) percentage (%) of participants achieving the outcome in each arm for combined depression and CVD risk factor improvements (≥50% reduction in SCL-20 score AND ≥1 of: ≥0.5% reduction in HbA1c, ≥ 5 mmHg reduction in systolic blood pressure (SBP), or ≥10mg/dl reduction LDL-c).
Measured: 24-months post-intervention
Secondary outcomes (13)
Measures of "Common Effect"
The measure of common effect is a modeled composite estimate of patients achieving simultaneous improvements at 12, 24, and 36 months in the continuous measures for the 4 main outcomes of the trial: depression (20-item Symptoms Checklist [SCL-20] score), glycemia (percentage points in hemoglobin A1c), blood pressure (mmHg of BP), and lipids (mg/dl of LDL-cholesterol).The components of the common effect were standardized differences in each continuous outcome. At each time point, the z-score of each outcome was computed. Next, a model was run to examine the average difference between treatment (intervention) and control in the average level of the standardized outcomes. The estimates are z-score differences in the composite continuous measures of the SCL-20, hemoglobin A1c, systolic BP, and LDL-cholesterol and so, if the intervention group was significantly different (or lower) than the values for the usual care group (control arm), then, the estimates would be negative.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups
Proportion of participants in the intervention and usual care groups that achieved all 3 cardiovascular disease risk factor targets: HbA1c≤7.0% and SBP≤130mmHg and LDL≤100 mg/dl.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Changes in Each of the Four Main Targets: SCL-20 Score
This outcome was an estimate of mean change, from baseline, of the 20-item Symptoms Checklist Depression Scale (SCL-20; range 0-4; higher scores indicate worse symptoms) for the intervention and usual care groups. The outcome was reported as a change in score from baseline at 12 months, 24 months, and 36 months with 95% confidence intervals.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Changes in Each of the Four Main Targets: HbA1c
This outcome looked at mean change in one of the four main target outcome indicators: HbA1c in percentage points between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Changes in Each of the Four Main Targets: SBP
This outcome looked at mean change in one of the four main target outcome indicators: Systolic blood pressure (SBP) in mmHg between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl
This outcome looked at mean change in one of the four main target outcome indicators: LDL-c in mg/dl between the treatment and usual care groups at 12 months, 24 and 36 months post-intervention.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20
Proportion of participants achieving treatment target or significant reductions in depression control: ≥50% reduction in SCL-20 at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control
Proportion of participants achieving a treatment target of HbA1c ≤ 7.0% or ≥ 0.5% reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure
Proportion of participants achieving treatment targets or significant reductions of blood pressure (BP) control: Systolic blood pressure (SBP) ≤ 130 mmHg or ≥5 mmHg reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control
Proportion of participants achieving treatment targets or significant reductions of lipid control: LDL ≤ 100 mg/dl or ≥ 10mg/dl reduction at 12, 24 and 36 months post-intervention. Greater proportion of participants achieving this target, correlates with better outcome.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Treatment Satisfaction Scores
Mean charges in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) in the intervention and usual care groups. Score range is 0-6. Higher score is associated with better outcome.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Health Expenditures (Direct Medical Costs)
Mean of direct medical costs for consultations, diagnostic tests, medications, hospital admissions, and/or surgeries or procedures) among participants in the treatment and usual care groups.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Cost Utility in the Treatment Arm and Usual Care Arms
The ratio of total costs, which include health expenditures by participants plus clinic or study costs to deliver the intervention and the relative gain or loss in health utilities (measured by the health utilities index). The within-trial cost-utility of intervention was compared to usual care, an incremental cost-utility ratio will be calculated [net costs to net utility: costs(intervention) - costs(control) / utility(intervention) - utility(control)]. The chosen measure of utility is the closest option to a global measure, the quality adjusted life year [QALY] and is calculated as the sum of mean survival time [life years] x utility scores at 6, 12, 18, 24 and 36 months.
Measured: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startMar 2014
- Primary completion14 Jul 2018
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Washington, Madras Diabetes Research Foundation, All India Institute of Medical Sciences, Endocrine & Diabetes Centre, Diacon Hospital
- Responsible party
- Principal investigator, Mohammed K Ali, MD, MSc, MBA, Emory University
- Investigators
- Viswanathan Mohan, MD, PhD, Principal investigator, Dr Mohan's Diabetes Specialities ClinicMohammed K Ali, MBChB, MSc, Principal investigator, Emory UniversityLydia Chwastiak, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022111
- Sponsor's protocol ID
- IRB00064913
- Other IDs
- R01MH100390-01
- Acronym
- INDEPENDENT
- Status last verified
- Apr 2021
- First submitted
- 17 Dec 2013
- Last updated
- 3 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Donabedian A. The end results of health care: Ernest Codman's contribution to quality assessment and beyond. Milbank Q. 1989;67(2):233-56; discussion 257-67.
PubMed 2698445Detsky AS, Naglie IG. A clinician's guide to cost-effectiveness analysis. Ann Intern Med. 1990 Jul 15;113(2):147-54. doi: 10.7326/0003-4819-113-2-147.
PubMed 2113784Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
PubMed 21190455CARRS Trial Writing Group; Shah S, Singh K, Ali MK, Mohan V, Kadir MM, Unnikrishnan AG, Sahay RK, Varthakavi P, Dharmalingam M, Viswanathan V, Masood Q, Bantwal G, Khadgawat R, Desai A, Sethi BK, Shivashankar R, Ajay VS, Reddy KS, Narayan KM, Prabhakaran D, Tandon N. Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Diabetes Res Clin Pract. 2012 Nov;98(2):285-94. doi: 10.1016/j.diabres.2012.09.023. Epub 2012 Oct 22.
PubMed 23084280Halliday S, Rao D, Augusto O, Poongothai S, Sosale A, Sridhar GR, Tandon N, Sagar R, Patel SA, Narayan KMV, Johnson LCM, Wagenaar BH, Huh D, Flaherty BP, Chwastiak LA, Ali MK, Mohan V; INDEPENDENT Study Group. A mediation analysis evaluating change in self-stigma on diabetes outcomes among people with depression in urban India: A secondary analysis from the INDEPENDENT trial of the collaborative care model. PLOS Glob Public Health. 2024 Sep 4;4(9):e0003624. doi: 10.1371/journal.pgph.0003624. eCollection 2024.
PubMed 39231130Hassan S, Liu S, Johnson LCM, Patel SA, Emmert-Fees KMF, Suvada K, Tandon N, Sridhar GR, Aravind S, Poongothai S, Anjana RM, Mohan V, Chwastiak L, Ali MK. Association of collaborative care intervention features with depression and metabolic outcomes in the INDEPENDENT study: A mixed methods study. Prim Care Diabetes. 2024 Jun;18(3):319-326. doi: 10.1016/j.pcd.2024.02.001. Epub 2024 Feb 15.
PubMed 38360505Suvada K, Ali MK, Chwastiak L, Poongothai S, Emmert-Fees KMF, Anjana RM, Sagar R, Shankar R, Sridhar GR, Kasuri M, Sosale AR, Sosale B, Rao D, Tandon N, Narayan KMV, Mohan V, Patel SA. Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. J Gen Intern Med. 2023 May;38(7):1623-1630. doi: 10.1007/s11606-022-07958-8. Epub 2023 Jan 3.
PubMed 36596908Ali MK, Chwastiak L, Poongothai S, Emmert-Fees KMF, Patel SA, Anjana RM, Sagar R, Shankar R, Sridhar GR, Kosuri M, Sosale AR, Sosale B, Rao D, Tandon N, Narayan KMV, Mohan V; INDEPENDENT Study Group. Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India: The INDEPENDENT Randomized Clinical Trial. JAMA. 2020 Aug 18;324(7):651-662. doi: 10.1001/jama.2020.11747.
PubMed 32809002Kowalski AJ, Poongothai S, Chwastiak L, Hutcheson M, Tandon N, Khadgawat R, Sridhar GR, Aravind SR, Sosale B, Anjana RM, Rao D, Sagar R, Mehta N, Narayan KMV, Unutzer J, Katon W, Mohan V, Ali MK. The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study: Design and methods to address mental healthcare gaps in India. Contemp Clin Trials. 2017 Sep;60:113-124. doi: 10.1016/j.cct.2017.06.013. Epub 2017 Jun 19.
PubMed 28642211
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) Study
- ClinicalTrials.gov ID
- NCT02022111
- Acronym / sponsor ID
- INDEPENDENT / IRB00064913
- Conditions
- Diabetes, Depression, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Washington, Madras Diabetes Research Foundation, All India Institute of Medical Sciences, Endocrine & Diabetes Centre, Diacon Hospital
- Study start
- Mar 2014
- Primary completion
- 14 Jul 2018 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Posted 14 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 four 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Program of Care | Active comparator | Behavioral: Patient Education and Behavioral Activation, Behavioral: Supporting Self-Care (care coordinators), Other: Psychiatrist and Diabetologist Reviews, Other: Decision-support Electronic Health Record System1. 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 |
| Control Arm | Placebo comparator | Other: Standard of CareParticipants randomized to the control arm will receive the existing standard of 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Education and Behavioral ActivationTo 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. | Behavioural | Intervention Program of Care |
| 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. | Behavioural | Intervention Program of Care |
| Psychiatrist and Diabetologist ReviewsSenior psychiatrist and endocrinologist/diabetologist will be involved in weekly offline 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 and their usual care providers. | Other | Intervention Program of Care |
| Decision-support Electronic Health Record SystemThe 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). | Other | Intervention Program of Care |
| Standard of CareParticipants 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. | Other | Control Arm |
Primary outcome
Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors
Time frame: 24-months post-intervention
The sustained (24-month) percentage (%) of participants achieving the outcome in each arm for combined depression and CVD risk factor improvements (≥50% reduction in SCL-20 score AND ≥1 of: ≥0.5% reduction in HbA1c, ≥ 5 mmHg reduction in systolic blood pressure (SBP), or ≥10mg/dl reduction LDL-c).
13 secondary outcomes
Measures of "Common Effect"
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving All 3 CVD Risk Factor Targets in the Two Groups
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Changes in Each of the Four Main Targets: SCL-20 Score
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Changes in Each of the Four Main Targets: HbA1c
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Changes in Each of the Four Main Targets: SBP
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Changes in Each of the Four Main Targets: LDL-c in mg/dl
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: SCL-20
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Glycemic Control
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Blood Pressure
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Proportion of Participants Achieving Treatment Targets or Significant Reductions in Individual Risk Factors: Lipid Control
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Treatment Satisfaction Scores
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Mean Health Expenditures (Direct Medical Costs)
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Cost Utility in the Treatment Arm and Usual Care Arms
Time frame: 12 months post-intervention, 24 months post-intervention, 36 months post-intervention (post-hoc follow up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2698445Donabedian A. The end results of health care: Ernest Codman's contribution to quality assessment and beyond. Milbank Q. 1989;67(2):233-56; discussion 257-67.
- Background: PubMed 2113784Detsky AS, Naglie IG. A clinician's guide to cost-effectiveness analysis. Ann Intern Med. 1990 Jul 15;113(2):147-54. doi: 10.7326/0003-4819-113-2-147.
- Background: PubMed 21190455Katon WJ, Lin EH, Von Korff M, Ciechanowski P, Ludman EJ, Young B, Peterson D, Rutter CM, McGregor M, McCulloch D. Collaborative care for patients with depression and chronic illnesses. N Engl J Med. 2010 Dec 30;363(27):2611-20. doi: 10.1056/NEJMoa1003955.
- Background: PubMed 23084280CARRS Trial Writing Group; Shah S, Singh K, Ali MK, Mohan V, Kadir MM, Unnikrishnan AG, Sahay RK, Varthakavi P, Dharmalingam M, Viswanathan V, Masood Q, Bantwal G, Khadgawat R, Desai A, Sethi BK, Shivashankar R, Ajay VS, Reddy KS, Narayan KM, Prabhakaran D, Tandon N. Improving diabetes care: multi-component cardiovascular disease risk reduction strategies for people with diabetes in South Asia--the CARRS multi-center translation trial. Diabetes Res Clin Pract. 2012 Nov;98(2):285-94. doi: 10.1016/j.diabres.2012.09.023. Epub 2012 Oct 22.
- Derived from this study: PubMed 39231130Halliday S, Rao D, Augusto O, Poongothai S, Sosale A, Sridhar GR, Tandon N, Sagar R, Patel SA, Narayan KMV, Johnson LCM, Wagenaar BH, Huh D, Flaherty BP, Chwastiak LA, Ali MK, Mohan V; INDEPENDENT Study Group. A mediation analysis evaluating change in self-stigma on diabetes outcomes among people with depression in urban India: A secondary analysis from the INDEPENDENT trial of the collaborative care model. PLOS Glob Public Health. 2024 Sep 4;4(9):e0003624. doi: 10.1371/journal.pgph.0003624. eCollection 2024.
- Derived from this study: PubMed 38360505Hassan S, Liu S, Johnson LCM, Patel SA, Emmert-Fees KMF, Suvada K, Tandon N, Sridhar GR, Aravind S, Poongothai S, Anjana RM, Mohan V, Chwastiak L, Ali MK. Association of collaborative care intervention features with depression and metabolic outcomes in the INDEPENDENT study: A mixed methods study. Prim Care Diabetes. 2024 Jun;18(3):319-326. doi: 10.1016/j.pcd.2024.02.001. Epub 2024 Feb 15.
- Derived from this study: PubMed 36596908Suvada K, Ali MK, Chwastiak L, Poongothai S, Emmert-Fees KMF, Anjana RM, Sagar R, Shankar R, Sridhar GR, Kasuri M, Sosale AR, Sosale B, Rao D, Tandon N, Narayan KMV, Mohan V, Patel SA. Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. J Gen Intern Med. 2023 May;38(7):1623-1630. doi: 10.1007/s11606-022-07958-8. Epub 2023 Jan 3.
- Derived from this study: PubMed 32809002Ali MK, Chwastiak L, Poongothai S, Emmert-Fees KMF, Patel SA, Anjana RM, Sagar R, Shankar R, Sridhar GR, Kosuri M, Sosale AR, Sosale B, Rao D, Tandon N, Narayan KMV, Mohan V; INDEPENDENT Study Group. Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India: The INDEPENDENT Randomized Clinical Trial. JAMA. 2020 Aug 18;324(7):651-662. doi: 10.1001/jama.2020.11747.
- Derived from this study: PubMed 28642211Kowalski AJ, Poongothai S, Chwastiak L, Hutcheson M, Tandon N, Khadgawat R, Sridhar GR, Aravind SR, Sosale B, Anjana RM, Rao D, Sagar R, Mehta N, Narayan KMV, Unutzer J, Katon W, Mohan V, Ali MK. The INtegrating DEPrEssioN and Diabetes treatmENT (INDEPENDENT) study: Design and methods to address mental healthcare gaps in India. Contemp Clin Trials. 2017 Sep;60:113-124. doi: 10.1016/j.cct.2017.06.013. Epub 2017 Jun 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viswanathan Mohan, MD, PhD principal investigator
Dr Mohan's Diabetes Specialities Clinic
Mohammed K Ali, MBChB, MSc principal investigator
Emory University
Lydia Chwastiak, MD principal investigator
University of Washington
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education and Behavioral Activation, Supporting Self-Care (care coordinators) and Psychiatrist and Diabetologist Reviews in people with Diabetes and Depression, run by Emory University at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Combined Improvement of Depressive Symptoms and CVD Risk Factors (time frame: 24-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022111, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.