Acute Coronary SyndromesI-CareNCT02195193
Integrating Depression Care in Acute Coronary Syndromes Care in China
A study testing Integrated care in people with Acute Coronary Syndromes and Depression, run by The George Institute for Global Health, China at 1 site in China.
Trial summary
The overall goal of this study is to develop, pilot test, implement, and evaluate a nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost in rural China. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Acute Coronary Syndromes, Depression
- What is being tested?
- Integrated care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,043 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 79 years old
- Hospitalized due to a diagnosis of Acute Coronary Syndromes (ACS)
- ACS is stable (as judged by the treating cardiologist/internist)
- Signed patient informed consent
Who cannot join
- Affected by severe cardiovascular disease or medical comorbidity that indicate the patient's life expectancy is less than 12 months (e.g. class IV heart failure, terminal cancer)
- Seriously disabled (unable to travel to the hospital, class IV heart failure at baseline)
- Suffering from problems that affect normal communication (e.g., intellectual impairment, observed mental confusion suggesting dementia, deafness, blindness, etc.)
- Non-permanent local residents or permanent residents planning to move out within 12 months
- Pregnant or breast-feeding or planning pregnancy within 12 months
- Affected by bipolar disorder, schizophrenia or severe depression that meet criteria for referral including patients with acutely suicidal risk (Beck Depression Inventory Item9=3)
- Having alcohol dependence (defined by MINI Alcohol Dependence/Abuse Part)
Trial locations and contacts
1 site in 1 country.
China1 site
The George Institute for Global Health, China
Haidian, Beijing Municipality, 100088
About this study
Official title: Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China
The overall goal of this study is to develop, pilot test, implement, and evaluate a nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS patients from 20 rural county hospitals selected from a well-established research network across China.
- Conditions
- Acute Coronary Syndromes, Depression
- Being tested
- Integrated care
- Keywords
- Health Services Research, Acute Coronary Syndromes, Depression, Integrated care
- Medical subject headings
- Acute Coronary Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated careOther
an integrated care model for ACS and depression delivered by a collaborative team composed of cardiologists/internists and nurses in the same rural county hospital. The collaborative team will be able to provide medical services for the diagnosis and treatment at acute phase of ACS during hospitalization, ACS secondary prevention therapies at and after discharge, and screening and treatment of depression depressive symptom during hospitalization and after discharge. The core of the interventions includes: depressidepressive symptomon screening and classification, individual counseling and medical treatment of depression, group counseling and health education, and follow-up for ACS and depression treatments compliance, IT- system- assisting theassisted management and necessary referral.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (UC) | No intervention | The standard interventions from Clinical Pathway for Acute Coronary Syndromes in China-Phase 3 (CPACS-3) study that are limited to in-patient ACS care (refer to "Usual Care" [UC]), will be implemented in the participating hospitals, and hence will be received by all patients in both intervention (IC) and control (UC) groups; standardized cardiovascular disease education also will be provided to all participants.CPACS-3 registration number is NCT01398228 |
| Intervention Care (IC) | Experimental | Besides of the UC, an nurse-coordinated integrated care model for Acute Coronary Syndromes(ACS) and depression will be delivered to intervention group, including ACS secondary prevention therapies at and after discharge, screening and treatment of depression during hospitalization and after discharge. Receives: Other: Integrated care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months
Measured: Before patient discharge and after 6 months from discharge
Changes in mean PHQ-9 score from baseline to 12 months
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months
Measured: Before patient discharge and after 12 months from discharge
Secondary outcomes (3)
Incidence of Major Adverse Cardiovascular Events (MACE)
MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease.
Measured: At least 12 months after discharge
Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months
ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker.
Measured: At 6 and 12 months after discharge
Quality of life (EQ5D) at 6 and 12 months after discharge
Measured: At 6 and 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- 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
- 4,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute for Global Health, China
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Peking University Sixth Hospital
- Responsible party
- Sponsor
- Investigators
- Yangfeng Wu, MD, PhD, Principal investigator, The Geogre Institute for Global Health, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195193
- Sponsor's protocol ID
- I-CARE
- Other IDs
- R01MH100332
- Acronym
- I-Care
- Status last verified
- May 2018
- First submitted
- 15 Jul 2014
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu Y, Yu X, Zhu Y, Shi C, Li X, Jiang R, Niu S, Gao P, Li S, Yan L, Maulik PK, Guo G, Patel A, Gao R, Blumenthal JA. Integrating depression and acute coronary syndrome care in low resource hospitals in China: the I-CARE randomised clinical trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101126. doi: 10.1016/j.lanwpc.2024.101126. eCollection 2024 Jul.
PubMed 39040037
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China
- ClinicalTrials.gov ID
- NCT02195193
- Acronym / sponsor ID
- I-Care / I-CARE
- Conditions
- Acute Coronary Syndromes, Depression
- Keywords
- Health Services Research, Acute Coronary Syndromes, Depression, Integrated care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,043 participants (actual)
- Lead sponsor
- The George Institute for Global Health, ChinaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Peking University Sixth Hospital
- Study start
- Nov 2014 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to develop, pilot test, implement, and evaluate a nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS patients from 20 rural county hospitals selected from a well-established research network across China.
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 |
|---|---|---|
| Usual Care (UC) | No intervention | –The standard interventions from Clinical Pathway for Acute Coronary Syndromes in China-Phase 3 (CPACS-3) study that are limited to in-patient ACS care (refer to "Usual Care" [UC]), will be implemented in the participating hospitals, and hence will be received by all patients in both intervention (IC) and control (UC) groups; standardized cardiovascular disease education also will be provided to all participants.CPACS-3 registration number is NCT01398228 |
| Intervention Care (IC) | Experimental | Other: Integrated careBesides of the UC, an nurse-coordinated integrated care model for Acute Coronary Syndromes(ACS) and depression will be delivered to intervention group, including ACS secondary prevention therapies at and after discharge, screening and treatment of depression during hospitalization and after discharge. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 to 79 years old
- Hospitalized due to a diagnosis of Acute Coronary Syndromes (ACS)
- ACS is stable (as judged by the treating cardiologist/internist)
- Signed patient informed consent
Key exclusion criteria (7 listed)
- Affected by severe cardiovascular disease or medical comorbidity that indicate the patient's life expectancy is less than 12 months (e.g. class IV heart failure, terminal cancer)
- Seriously disabled (unable to travel to the hospital, class IV heart failure at baseline)
- Suffering from problems that affect normal communication (e.g., intellectual impairment, observed mental confusion suggesting dementia, deafness, blindness, etc.)
- Non-permanent local residents or permanent residents planning to move out within 12 months
- Pregnant or breast-feeding or planning pregnancy within 12 months
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 |
|---|---|---|
| Integrated carean integrated care model for ACS and depression delivered by a collaborative team composed of cardiologists/internists and nurses in the same rural county hospital. The collaborative team will be able to provide medical services for the diagnosis and treatment at acute phase of ACS during hospitalization, ACS secondary prevention therapies at and after discharge, and screening and treatment of depression depressive symptom during hospitalization and after discharge. The core of the interventions includes: depressidepressive symptomon screening and classification, individual counseling and medical treatment of depression, group counseling and health education, and follow-up for ACS and depression treatments compliance, IT- system- assisting theassisted management and necessary referral. | Other | Intervention Care (IC) |
Primary outcome
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months
Time frame: Before patient discharge and after 6 months from discharge
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months
Changes in mean PHQ-9 score from baseline to 12 months
Time frame: Before patient discharge and after 12 months from discharge
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months
3 secondary outcomes
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: At least 12 months after discharge
Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months
Time frame: At 6 and 12 months after discharge
Quality of life (EQ5D) at 6 and 12 months after discharge
Time frame: At 6 and 12 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Derived from this study: PubMed 39040037Wu Y, Yu X, Zhu Y, Shi C, Li X, Jiang R, Niu S, Gao P, Li S, Yan L, Maulik PK, Guo G, Patel A, Gao R, Blumenthal JA. Integrating depression and acute coronary syndrome care in low resource hospitals in China: the I-CARE randomised clinical trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101126. doi: 10.1016/j.lanwpc.2024.101126. eCollection 2024 Jul.
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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.
Yangfeng Wu, MD, PhD principal investigator
The Geogre Institute for Global Health, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated care in people with Acute Coronary Syndromes and Depression, run by The George Institute for Global Health, China at 1 site in China.
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 4 inclusion and 7 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months (time frame: Before patient discharge and after 6 months from discharge). The study lists 2 primary outcomes in all. 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 NCT02195193, which also lists 1 linked publication.
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 21 May 2018.