Transitional Care ModelNCT07346664
Medication Adherence and Lipid Management in Patients With Coronary Heart Disease After Percutaneous Coronary Intervention: Application of the Transitional Care Model
A study testing routine nursing care group and TCM intervention group in people with Transitional Care Model and Coronary Heart Disease, run by Qing Wang at 1 site in China.
Trial summary
Patients with coronary heart disease (CHD) require long-term medication and lifestyle modification following percutaneous coronary intervention (PCI). However, they often face challenges such as poor medication adherence and inadequate self-management. Read more about this study
- Who is it for?
- Ages 47 to 58 years
- Conditions the study is for
- Transitional Care Model, Coronary Heart Disease, Medication Adherence
- What is being tested?
- routine nursing care group and TCM intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2022to 26 May 2024
- 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 47 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients clinically diagnosed with CHD according to established diagnostic criteria
- patients who met the World Health Organization (WHO) indications for PCI
- complete clinical data available
Who cannot join
- Patients with cognitive impairment
- Patients with incomplete follow-up data.
- Patients with comorbid malignancy
- Patients with severe hepatic
- Patients with renal insufficiency
Trial locations and contacts
1 site in 1 country.
China1 site
Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Yangzhou, Jiangsu, 225001
About this study
Official title: Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Patients with coronary heart disease (CHD) require long-term medication and lifestyle modification following percutaneous coronary intervention (PCI). However, they often face challenges such as poor medication adherence and inadequate self-management. This study aims to evaluate the effects of the transitional care model (TCM) on CHD patients after PCI, regarding medication adherence, self-efficacy, and lipid levels.
Read the detailed description
TCM improved medication adherence, self-efficacy, and lipid profiles in CHD patients after PCI, while enhancing overall patient satisfaction. Compared with routine nursing care, TCM yielded superior clinical benefits and is recommended for broader application in the post-PCI management of CHD patients.
- Conditions
- Transitional Care Model, Coronary Heart Disease, Medication Adherence, Self-efficacy, Lipid Profile
- Being tested
- routine nursing care group, TCM intervention group
- Medical subject headings
- Coronary Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine nursing care groupOther
Patients assigned to the control group underwent routine nursing care based on the standardized medical treatment, including admission health education (PCI postoperative risk management and medication instructions), psychological counseling, dietary and exercise guidance, individualized rehabilitation planning, and discharge instructions. After discharge, patients attended routine outpatient follow-up visits, including laboratory testing of blood lipids, blood pressure, and blood glucose, without structured follow-up or WeChat-based education. Routine outpatient education and guidance were provided only.
TCM intervention groupOther
Patients in the observation group received a 3-month TCM intervention delivered by specially trained nurses, in addition to routine nursing care.
| Study group | Role | What they receive |
|---|---|---|
| routine nursing care group | Other | Patients assigned to the control group underwent routine nursing care based on the standardized medical treatment, including admission health education (PCI postoperative risk management and medication instructions), psychological counseling, dietary and exercise guidance, individualized rehabilitation planning, and discharge instructions. After discharge, patients attended routine outpatient follow-up visits, including laboratory testing of blood lipids, blood pressure, and blood glucose, without structured follow-up or WeChat-based education. Routine outpatient education and guidance were provided only. Receives: Other: routine nursing care group |
| TCM intervention group | Other | Patients in the observation group received a 3-month TCM intervention delivered by specially trained nurses, in addition to routine nursing care. Receives: Other: TCM intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Medication adherence will be assessed using the Medication Adherence Report Scale-5 (MARS-5). The scale consists of 5 items that evaluate nonadherent behaviors (e.g., forgetting to take medications, altering dosages). Each item is scored on a 5-point Likert scale (1="always" to 5="never"), with total scores ranging from 5 to 25. A higher total score indicates better medication adherence.
Measured: Baseline (before discharge) and 3 months after discharge
Secondary outcomes (2)
Self-efficacy
Self-efficacy will be assessed using the General Self-Efficacy Scale (GSS). The GSS is a validated 16-item instrument, with each item scored from 0 to 4. Higher total scores reflect greater self-efficacy in managing health and adhering to treatment recommendations.
Measured: Baseline (before discharge) and 3 months after discharge
Lipid Profile
Fasting serum levels of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be measured using an automated biochemical analyzer. All measurements will be performed in mmol/L.
Measured: Baseline (before discharge) and 3 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 posted16 Jan 2026
- Study start11 Jul 2022
- Primary completion9 May 2024
- Study completion26 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional Care ModelStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qing Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qing Wang, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346664
- Sponsor's protocol ID
- No. 20240410
- Status last verified
- Apr 2022
- First submitted
- 8 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northern Jiangsu People's Hospital Affiliated to Yangzhou University
- ClinicalTrials.gov ID
- NCT07346664
- Acronym / sponsor ID
- No. 20240410
- Conditions
- Transitional Care Model, Coronary Heart Disease, Medication Adherence, Self-efficacy, Lipid Profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Qing WangUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 26 May 2024 (actual)
- First posted
- 16 Jan 2026 (actual)
- 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.
Patients with coronary heart disease (CHD) require long-term medication and lifestyle modification following percutaneous coronary intervention (PCI). However, they often face challenges such as poor medication adherence and inadequate self-management. This study aims to evaluate the effects of the transitional care model (TCM) on CHD patients after PCI, regarding medication adherence, self-efficacy, and lipid levels.
Detailed description
TCM improved medication adherence, self-efficacy, and lipid profiles in CHD patients after PCI, while enhancing overall patient satisfaction. Compared with routine nursing care, TCM yielded superior clinical benefits and is recommended for broader application in the post-PCI management of CHD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine nursing care group | Other | Other: routine nursing care groupPatients assigned to the control group underwent routine nursing care based on the standardized medical treatment, including admission health education (PCI postoperative risk management and medication instructions), psychological counseling, dietary and exercise guidance, individualized rehabilitation planning, and discharge instructions. After discharge, patients attended routine outpatient follow-up visits, including laboratory testing of blood lipids, blood pressure, and blood glucose, without structured follow-up or WeChat-based education. Routine outpatient education and guidance were provided only. |
| TCM intervention group | Other | Other: TCM intervention groupPatients in the observation group received a 3-month TCM intervention delivered by specially trained nurses, in addition to routine nursing care. |
Who may qualify
- Ages
- 47 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients clinically diagnosed with CHD according to established diagnostic criteria
- patients who met the World Health Organization (WHO) indications for PCI
- complete clinical data available
Key exclusion criteria (5 listed)
- Patients with cognitive impairment
- Patients with incomplete follow-up data.
- Patients with comorbid malignancy
- Patients with severe hepatic
- Patients with renal insufficiency
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 |
|---|---|---|
| routine nursing care groupPatients assigned to the control group underwent routine nursing care based on the standardized medical treatment, including admission health education (PCI postoperative risk management and medication instructions), psychological counseling, dietary and exercise guidance, individualized rehabilitation planning, and discharge instructions. After discharge, patients attended routine outpatient follow-up visits, including laboratory testing of blood lipids, blood pressure, and blood glucose, without structured follow-up or WeChat-based education. Routine outpatient education and guidance were provided only. | Other | routine nursing care group |
| TCM intervention groupPatients in the observation group received a 3-month TCM intervention delivered by specially trained nurses, in addition to routine nursing care. | Other | TCM intervention group |
Primary outcome
Medication Adherence
Time frame: Baseline (before discharge) and 3 months after discharge
Medication adherence will be assessed using the Medication Adherence Report Scale-5 (MARS-5). The scale consists of 5 items that evaluate nonadherent behaviors (e.g., forgetting to take medications, altering dosages). Each item is scored on a 5-point Likert scale (1="always" to 5="never"), with total scores ranging from 5 to 25. A higher total score indicates better medication adherence.
2 secondary outcomes
Self-efficacy
Time frame: Baseline (before discharge) and 3 months after discharge
Lipid Profile
Time frame: Baseline (before discharge) and 3 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 16 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine nursing care group and TCM intervention group in people with Transitional Care Model and Coronary Heart Disease, run by Qing Wang 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 3 inclusion and 5 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 16 Jan 2026. 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?
Medication Adherence (time frame: Baseline (before discharge) and 3 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.