Cardiometabolic DiseaseNCT06022575
Telehealth Integrated Care Model in Patients With Cardiometabolic Disease
An observational study of Cardiometabolic Disease and Hyperlipidemia, run by Peking University Third Hospital at 1 site in China.
Trial summary
The objective of this study is to evaluate the telehealth integrated care model for its clinical efficacy, medical resource utilization, health economics measurement, and satisfaction survey indicators in hyperlipidemia patients and other cardiometabolic diseases. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Cardiometabolic Disease, Hyperlipidemia
- What is being tested?
- Telehealth integrated care and Conventional health care
- Type of treatment
- Surgery or procedure
- How many people
- 1,302 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2023to 20 Jul 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 16 to 85 years
- All sexes
- Child, Adult, Older adult
Study population: Cardiometabolic Disease
Who may be able to join
- Age ≥ 16 years, and ≤ 85 years;
- Diagnosis as hyperlipidemia with at least one of the following disease: hypertension or type 2 diabetes mellitus;
- Agreed to be enrolled in this study.
Who cannot join
- Undergone percutaneous coronary intervention within one year in our hospital;
- Severe LV dysfunction, such as LV ejection fraction < 35%, or congestive heart failure with New York Heart Association (NYHA) functional class IV or Killip class IV;
- Structural heart disease, or severe arrhythmia;
- Severe liver or kidney diseases, endocrinology diseases, hematologic diseases, rheumatic immune system diseases, and malignancy;
- could not complete at least one-year-followup.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Lequn Zhou, zhoulequnde@126.com
About this study
Official title: Evaluation of the Telehealth Integrated Care Model in Patients With Hyperlipidemia and Other Cardiometabolic Disease
The objective of this study is to evaluate the telehealth integrated care model for its clinical efficacy, medical resource utilization, health economics measurement, and satisfaction survey indicators in hyperlipidemia patients and other cardiometabolic diseases. The result of the study will provide evidence for the value of integrated model in the treatment of patients with cardiometabolic syndrome.
Read the detailed description
Efficacy evaluation is critical for understanding the practical application effect of telehealth integrated mode in the therapy of cardiometabolic disease patients. We can comprehend the influence of the combination of online and offline models on patients' clinical curative effect, medication compliance, medical cost, and satisfaction by analyzing the curative effect and finding a scientific basis for clinical practice and policy formation. As a result, the purpose of this study is to assess the curative effect of hyperlipidemia patients with other cardiometabolic disease using a telehealth integrated model, as well as to investigate the potential benefits and risks of this model in the management of cardiometabolic disease.
- Conditions
- Cardiometabolic Disease, Hyperlipidemia
- Being tested
- Telehealth integrated care, Conventional health care
- Keywords
- Telehealth, Cardiometabolic Disease, Hyperlipidemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth integrated careProcedure or surgery
Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly.
Conventional health careProcedure or surgery
Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Integrated Care Group | Followed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly. Receives: Procedure: Telehealth integrated care | |
| Conventional Group | Followed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education. Receives: Procedure: Conventional health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of compliance rate of target treatment for hyperlipidemia
difference of compliance rate of target treatment for hyperlipidemia between endpoint with baseline
Measured: 12 month after recuitment
Secondary outcomes (14)
changes of blood pressure
difference of blood pressure（both systolic and diastolic blood pressure will be measured.） between endpoint with baseline
Measured: 12 month after recuitment
changes of glycosylated hemoglobin
difference of glycosylated hemoglobin between endpoint with baseline
Measured: 12 month after recuitment
changes of fasting glucose
difference of fasting glucose between endpoint with baseline
Measured: 12 month after recuitment
changes of LDL-c
difference of LDL-c between endpoint with baseline
Measured: 12 month after recuitment
changes of triglyceride
difference of triglyceride between endpoint with baseline
Measured: 12 month after recuitment
abnormal liver function
an increase above the 3-fold normal value for ALT or AST.
Measured: 12 month after recuitment
abnormal kidney function
an increase in creatinine of ≥ 30%
Measured: 12 month after recuitment
Rehospitalization
Rehospitalization because of coronary heart disease, poor blood pressure control, and poor glycemic control
Measured: 12 month
Cardiovascular death
Death because of cardiovascular diseases and sudden death
Measured: 12 month
medication adherence rate
Difference of medication adherence between each group measured by Morisky Medication Adherence Scale-8
Measured: 12 month
patients satisfaction
patients will be asked to rate their satisfaction score in Likert form with 1 being the most unsatisfactory and 5 being the most satisfactory on the overall experience, the medical diagnosis process, service attitude and physician's professionalism.
Measured: 12 month
medical cost
Health Economics on medical cost, transportation cost, accommodation cost, waiting time and lost work time
Measured: 12 month
in person visit counts
total number of in person visits
Measured: 12 month after recuitment
telehealth visit counts
total number of telehealth visits
Measured: 12 month after recuitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start20 Jun 2023
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,302 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeng Lin, Ph. D., Peking University Third Hospital
- Investigators
- Lin Zeng, Ph.D, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022575
- Sponsor's protocol ID
- PekingUTH Telehealth
- Status last verified
- Sep 2023
- First submitted
- 7 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Telehealth Integrated Care Model in Patients With Hyperlipidemia and Other Cardiometabolic Disease
- ClinicalTrials.gov ID
- NCT06022575
- Acronym / sponsor ID
- PekingUTH Telehealth
- Conditions
- Cardiometabolic Disease, Hyperlipidemia
- Keywords
- Telehealth, Cardiometabolic Disease, Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,302 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 5 Sep 2023 (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.
The objective of this study is to evaluate the telehealth integrated care model for its clinical efficacy, medical resource utilization, health economics measurement, and satisfaction survey indicators in hyperlipidemia patients and other cardiometabolic diseases. The result of the study will provide evidence for the value of integrated model in the treatment of patients with cardiometabolic syndrome.
Detailed description
Efficacy evaluation is critical for understanding the practical application effect of telehealth integrated mode in the therapy of cardiometabolic disease patients. We can comprehend the influence of the combination of online and offline models on patients' clinical curative effect, medication compliance, medical cost, and satisfaction by analyzing the curative effect and finding a scientific basis for clinical practice and policy formation. As a result, the purpose of this study is to assess the curative effect of hyperlipidemia patients with other cardiometabolic disease using a telehealth integrated model, as well as to investigate the potential benefits and risks of this model in the management of cardiometabolic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Integrated Care Group | – | Procedure: Telehealth integrated careFollowed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly. |
| Conventional Group | – | Procedure: Conventional health careFollowed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiometabolic Disease
Key inclusion criteria (3 listed)
- Age ≥ 16 years, and ≤ 85 years;
- Diagnosis as hyperlipidemia with at least one of the following disease: hypertension or type 2 diabetes mellitus;
- Agreed to be enrolled in this study.
Key exclusion criteria (5 listed)
- Undergone percutaneous coronary intervention within one year in our hospital;
- Severe LV dysfunction, such as LV ejection fraction < 35%, or congestive heart failure with New York Heart Association (NYHA) functional class IV or Killip class IV;
- Structural heart disease, or severe arrhythmia;
- Severe liver or kidney diseases, endocrinology diseases, hematologic diseases, rheumatic immune system diseases, and malignancy;
- could not complete at least one-year-followup.
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 |
|---|---|---|
| Telehealth integrated careFollowed up in online Internet hospital, estimated and adjusted treatment accroding to clinical efficacy, and send individualized health education messages regularly. | Procedure or surgery | Telehealth Integrated Care Group |
| Conventional health careFollowed up face-to-face in cardiacmetabolic clinics, estimated and adjusted treatment accroding to clinical efficacy, and conducted health education. | Procedure or surgery | Conventional Group |
Primary outcome
changes of compliance rate of target treatment for hyperlipidemia
Time frame: 12 month after recuitment
difference of compliance rate of target treatment for hyperlipidemia between endpoint with baseline
14 secondary outcomes
changes of blood pressure
Time frame: 12 month after recuitment
changes of glycosylated hemoglobin
Time frame: 12 month after recuitment
changes of fasting glucose
Time frame: 12 month after recuitment
changes of LDL-c
Time frame: 12 month after recuitment
changes of triglyceride
Time frame: 12 month after recuitment
abnormal liver function
Time frame: 12 month after recuitment
abnormal kidney function
Time frame: 12 month after recuitment
Rehospitalization
Time frame: 12 month
Cardiovascular death
Time frame: 12 month
medication adherence rate
Time frame: 12 month
patients satisfaction
Time frame: 12 month
medical cost
Time frame: 12 month
in person visit counts
Time frame: 12 month after recuitment
telehealth visit counts
Time frame: 12 month after recuitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Lin Zeng, Ph.D principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiometabolic Disease and Hyperlipidemia, run by Peking University Third Hospital 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lequn Zhou, Dr (+86 1082266280, zhoulequnde@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of compliance rate of target treatment for hyperlipidemia (time frame: 12 month after recuitment). 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 5 Sep 2023.