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StrokeCOMPLIANCE-MTNCT05963828

Comprehensive Management of High-risk PopuLatIon for Stroke Based on Social Network

A study testing conventional care and Social network-based intervention in people with Stroke and Cerebrovascular Disorders, run by Changhai Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness of social network in improving drug compliance and risk factors control rate of stroke high-risk population after discharge. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Cerebrovascular Disorders, Brain Diseases
What is being tested?
conventional care and Social network-based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
1 siteChina
Study dates
19 Jul 2023to 30 Apr 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years.
  • Hospitalized patients at high risk of stroke are those who have at least three of the following risk factors: hypertension, dyslipidemia, diabetes, atrial fibrillation/valvular disease, smoking history, overweight/obesity, physical inactivity, or family stroke history; or those with a history of prior transient ischemic attack (TIA) or stroke.12
  • modified Rankin Scale (mRS) score ≤2.
  • Smartphone/WeChat access (patient or caregiver).
  • Informed consent obtained.
  • Active long-term therapy: ≥1 medication (antihypertensive, hypoglycemic, lipid-lowering, anticoagulant, antiplatelet).

Who cannot join

  • Inability to operate smartphones (patient or caregiver).
  • Comorbidities potentially confounding outcome assessments, including Advanced malignancies (life expectancy <12 months); Documented dementia; Severe psychiatric disorders (e.g., schizophrenia, major depressive disorder).
  • Residence in areas with unreliable internet access.
  • Concurrent participation in other clinical trials.
  • Any condition deemed by investigators to preclude safe trial participation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: COmprehensive Management of High-risk PopuLatIon for Stroke bAsed oN soCial nEtwork: A Multicenter Randomized Clinical Trial

The purpose of this study is to evaluate the effectiveness of social network in improving drug compliance and risk factors control rate of stroke high-risk population after discharge.

Read the detailed description

Stroke is the leading cause of death among residents in China, with the characteristics of high morbidity, high mortality, high disability rate, high recurrence rate and so on, which brings huge economic burden to the patients' families and society. Strengthening the comprehensive management of the high-risk population of stroke, improving the medication compliance of patients and the control rate of stroke risk factors play a key role in reducing stroke recurrence.

This study is a multicenter, prospective, randomized, single-blind study, which aims to use the tool of WeChat Mini Programs to realize the post-hospital follow-up management of the high-risk population of stroke. The follow-up time is 12 months. The main measurement result was the change of patients' medication compliance after comprehensive management.

Being tested
conventional care, Social network-based intervention
Keywords
Stroke, Management, Social Networks
Medical subject headings
Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional careBehavioural

    Patients in conventional care group will receive standardized education based on ASA/AHA 2021 guidelines prior to discharge,2 delivered verbally by a certified Brain-Heart Health Manager (BHHM) and supplemented with an expert-reviewed booklet. Content will cover medication adherence, risk factor control, stroke recognition, emergency response, and follow-up plans. A contact number will be provided for post-discharge support. A baseline archive will document demographics, lifestyle, and cardiovascular risk factors.

  • Social network-based interventionBehavioural

    Participants in Social network-based intervention group are onboard to the integrated digital platform. BHHMs facilitate the activation of the digital interface via a unique QR code, assist in the creation of a comprehensive electronic health record (EHR), and guide participants through an interactive tutorial to ensure technical proficiency in data entry and communication features.

Study groups in NCT05963828
Study groupRoleWhat they receive
conventional care groupOtherPatients are managed according to the conventional methods after enrollment.
Receives: Behavioral: conventional care
Social network-based intervention groupExperimentalPatients are managed according to to the integrated digital platform
Receives: Behavioral: Social network-based intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Good Medication Adherence to all guideline-recommended vascular prevention medications at 12 months post-discharge

    Adherence is assessed using self-reported data, with participants asked to indicate the number of days they missed taking a dose for each medication class during the preceding 30 days. This evaluation is conducted separately for each of the five evidence-based secondary prevention drug classes: antihypertensives, hypoglycemics, lipid-lowering agents, anticoagulants, and antiplatelets. Good adherence for each class is defined as taking the prescribed medication on more than 24 days out of the previous 30 days (corresponding to an adherence rate >80%). To meet the primary endpoint, a participant must achieve this >80% adherence threshold simultaneously across all five medication classes at the 12-month follow-up.

    Any self-directed cessation or adjustment of the regimen without medical consultation is categorized as non-adherence. Conversely, patients who cease or adjust their medications according to medical advice will be considered adherent. For those who adjust their medications base

    Measured: 12 months post-discharge

Secondary outcomes (12)

  1. Proportion of good medication adherence to stroke prevention drugs post-discharge

    Assessed using the Morisky-8 Medication Adherence Scale [MMAS-8]. Good adherence is defined as an MMAS-8 score greater than 6.The lowest score is 0, and the highest score is 8. A higher score indicates better adherence.

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  2. Risk factor control, including blood glucose(mmol/L), blood pressure(mmHg), lipid profile(mmol/L), body mass index (BMI) (kg/m ^ 2), waist circumference(cm), hip circumference(cm), and smoking status post-discharge.

    The method of measurement is as follows:

    Blood lipids(mmol/L): fasting blood sampling measurement Blood glucose(mmol/L): fasting fingertip blood glucose Blood pressure(mmHg): using a sphygmomanometer to measure BMI (kg/m ^ 2): weight(kg) / height (m ^ 2) Waist circumference(cm), Hip circumference(cm), Smoking: Patient self-report

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  3. Health-related quality of life (HRQoL)

    Assessed using the EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L),including visual analog scale (score range of 0-100, higher score indicates better health status) and utility score (score range of[ -0.391,1], higher score indicates better quality of life for patients)

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  4. Anxiety symptom severity

    assessed using the 7-item Generalized Anxiety Disorder Scale (GAD-7),the score range is 0-21 points, with higher scores indicating greater levels of anxiety.

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  5. Depressive symptom severity

    Assessed using the 9-item Patient Health Questionnaire (PHQ-9),the score range is 0-27 points, with higher scores indicating more severe depression.

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  6. Stroke prevention knowledge scores

    Assessed using the Stroke Prevention Knowledge Questionnaire,the score range is 0-36 points, with higher scores indicating better mastery of stroke related knowledge.

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  7. Personal motivation for stroke prevention

    Assessed using the Stroke Attitude Questionnaire,the total score is the sum of 16 items, and the higher the score, the better the cognitive attitude.

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  8. Perceived social support

    Assessed using the Perceived Social Support Scale (PSSS),there are a total of 12 items, with each item assigned a score of 1-7, for a total score of 12-84. The higher the score, the higher the individual's level of social support.

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  9. Stroke prevention-related health behavior scores

    Assessed using the Stroke Prevention Health Behavior Scale,the scale consists of 25 items and uses the Likert 4-point scoring method. The higher the total score, the higher the level of healthy behavior.

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  10. Self-efficacy for chronic disease management

    Assessed using the Chronic Disease Self-Efficacy Scale,the scale consists of 6 items, with each item rated on a scale of 1-10. The average score is taken, and the higher the average score, the stronger the self-efficacy.

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  11. Intentions regarding prehospital delay in stroke emergency care

    Assessed using the Prehospital Delay Behavior Intention Scale for Stroke,the scale consists of 27 items and uses the Likert 5-point scoring method, with a score range of 27-135 points. The higher the score, the stronger the intention and likelihood of delaying medical treatment.

    Measured: 1 month, 3 months, 6 months and 12 months post-discharge

  12. Incidence of major adverse cerebrovascular and cardiovascular events (MACCE)

    Including stroke, acute coronary syndrome, and vascular death

    Measured: 1month, 3months, 6months and 12-months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start19 Jul 2023
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05963828
Sponsor's protocol ID
COMPLIANCE-MT
Acronym
COMPLIANCE-MT
Status last verified
Jan 2026
First submitted
14 Apr 2023
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual, de-identified participant data used in these analyses will be shared by request from any qualified investigator following approval of a protocol and signed data access agreement via both the trial steering committee.

Publications

  • Xu, A.D. Building a bridge between guidelines and practice to standardize secondary prevention of ischemic stroke/transient ischemic attack in China [J].Stroke,20105(6):429-430. https://doi.org/10.3969/j.issn.1673-5765.2010.06.002

  • Bridgwood B, Lager KE, Mistri AK, Khunti K, Wilson AD, Modi P. Interventions for improving modifiable risk factor control in the secondary prevention of stroke. Cochrane Database Syst Rev. 2018 May 7;5(5):CD009103. doi: 10.1002/14651858.CD009103.pub3.

    PubMed 29734470

  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.

    PubMed 28122885

  • Chen, W. W., Gao, R. L., Liu, L. S., et al.Summary of the 2017 China Cardiovascular Disease Report[J]. Chinese Circulation Journal,2018,33(1):1-8.

  • GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

    PubMed 30496104

  • Zhang T, Zhao J, Li X, Bai Y, Wang B, Qu Y, Li B, Zhao S; Chinese Stroke Association Stroke Council Guideline Writing Committee. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of stroke rehabilitation. Stroke Vasc Neurol. 2020 Sep;5(3):250-259. doi: 10.1136/svn-2019-000321. Epub 2020 Jun 28.

    PubMed 32595138

  • National Health Commission of the People's Republic of China. Management Measures for the Pilot Program on Screening and Intervention for High-RiskPopulations of Apoplexy (Trial)[EB/OL].[2023-06-28].http://www.nhc.gov.cn/wjw/gfxwj/201304/3dca42b696ad411da36e8b5b9321 d8e3.shtml.

  • Turan TN, Nizam A, Lynn MJ, Egan BM, Le NA, Lopes-Virella MF, Hermayer KL, Harrell J, Derdeyn CP, Fiorella D, Janis LS, Lane B, Montgomery J, Chimowitz MI. Relationship between risk factor control and vascular events in the SAMMPRIS trial. Neurology. 2017 Jan 24;88(4):379-385. doi: 10.1212/WNL.0000000000003534. Epub 2016 Dec 21.

    PubMed 28003500

  • Labarthe DR, Biggers A, LaPier T, George MG; Paul Coverdell National Acute Stroke Registry. The Paul Coverdell National Acute Stroke Registry (PCNASR): a public health initiative. Am J Prev Med. 2006 Dec;31(6 Suppl 2):S192-5. doi: 10.1016/j.amepre.2006.07.027. No abstract available.

    PubMed 17178302

  • Chen, Y. X., Jiang, Y., Li, Z. X., et al. Current status of medication adherence in secondary prevention of acute ischemic stroke and transient ischemic attack in China[J].Chinese Journal of Stroke,2018,13(7):686-691.

  • Kim GG, Chae DH, Park MS, Yoo SH. Factors Influencing 1-Year Medication Adherence of Korean Ischemic Stroke Survivors. Int J Behav Med. 2020 Apr;27(2):225-234. doi: 10.1007/s12529-020-09854-z.

    PubMed 32026290

  • Ranganai E, Matizirofa L. An analysis of recent stroke cases in South Africa: Trend, seasonality and predictors. S Afr Med J. 2020 Jan 29;110(2):92-99. doi: 10.7196/SAMJ.2020.v110i2.013891.

    PubMed 32657676

  • Glader EL, Sjolander M, Eriksson M, Lundberg M. Persistent use of secondary preventive drugs declines rapidly during the first 2 years after stroke. Stroke. 2010 Feb;41(2):397-401. doi: 10.1161/STROKEAHA.109.566950. Epub 2010 Jan 14.

    PubMed 20075360

  • He, S. (2017). Development of a medication reminder app and its study on improving medication adherence [Master's thesis/Doctoral dissertation]. Anhui Medical University.

  • Li, M., Gai, H. Y., & Chen, H. Application of cloud follow-up platform in continuous nursing of hemiplegic patients during recovery period of ischemic stroke[J].Chongqing Medicine,2020,49(17):2956-2961.

Questions about this trial

What is this clinical trial studying?

A study testing conventional care and Social network-based intervention in people with Stroke and Cerebrovascular Disorders, run by Changhai 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 6 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 12 May 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?

Good Medication Adherence to all guideline-recommended vascular prevention medications at 12 months post-discharge (time frame: 12 months post-discharge). 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 NCT05963828, which also lists 31 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 12 May 2026.

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