Stroke
Conditions
Interventions
Observational group:None
Sponsors
The Second People’s Hospital of Neijiang
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Phase 1: Scale Translation and Cross-Cultural Adaptation This phase does not involve participant enrolment. Phase 2: Cognitive Interview Inclusion criteria: 1. Aged 18 years or older; 2. Patients with a confirmed diagnosis of stroke (either ischaemic or haemorrhagic), whose condition is stable; 3. Able to understand and express their views on the items; 4. Complete medical records, with access to basic clinical data; 5. Willing to participate and sign an informed consent form. Phase 3: Psychometric Validation of the Scale Inclusion criteria: 1. Aged 18 years or older; 2. Patients with a confirmed diagnosis of stroke (either ischaemic or haemorrhagic), with stable clinical condition; 3. Currently receiving treatment with at least one secondary prevention medication for stroke (antiplatelet, lipid-lowering, antihypertensive or anticoagulant drugs); 4. Able to complete the questionnaire (family members may assist with reading, but the patient must decide the answers); 5. Complete medical records, with access to basic clinical data; 6. Willing to participate and sign an informed consent form. Phase Four: Epidemiological Survey Inclusion criteria: 1. Aged 18 years or older; 2. Patients with a confirmed diagnosis of stroke (either ischaemic or haemorrhagic); 3. >=1 month post-discharge and in a stable follow-up phase; 4. Currently taking or having previously taken secondary prevention medication for stroke; 5. Able to understand or complete the questionnaire with the help of a carer; 6. Willing to participate and sign an informed consent form. Phase Five: Qualitative Interviews on Medication Adherence and Behaviour Inclusion criteria: 1. Aged >=18 years; 2. Stroke patients with stable condition and clear awareness/consciousness; 3. Able to participate in a 20–40-minute interview and possess communication skills (mild impairment permitted; assistance from family members allowed); 4. Willing to discuss their medication experiences, difficulties and feelings; 5. Priority will be given to those who have participated in the quantitative surveys of Phase 3 or 4, but this is not a mandatory requirement; 6. Willing to participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Phase 1: Scale Translation and Cross-Cultural Adaptation This phase does not involve patients; therefore, there are no exclusion criteria. Phase 2: Cognitive Interview Exclusion criteria: 1. Impaired consciousness, acute confusion, or inability to cooperate with the interview; 2. Marked aphasia without a suitable carer present to assist; 3. Patients in the acute phase of stroke (onset <30 days) or with unstable condition; 4. Severe hearing or language communication impairments affecting the quality of the interview; 5. Individuals unwilling to participate or unable to complete the interview. Phase Three: Psychometric Validation of the Scale Exclusion criteria: 1. Patients in the acute phase of stroke (onset <30 days) or with unstable clinical condition; 2. Individuals unable to complete the questionnaire, including those with impaired consciousness, severe cognitive impairment, or severe aphasia; 3. Patients not currently receiving any secondary prevention medication for stroke (as compliance cannot be assessed); 4. Patients with severe mental disorders (e.g. schizophrenia, bipolar disorder) affecting the reliability of self-reports; 5. Patients with end-stage diseases or those receiving inpatient hospice/palliative care; 6. Those unwilling to participate in the study or who withdraw their informed consent. Phase IV: Epidemiological Survey Exclusion criteria: 1. Those with an unclear clinical diagnosis or insufficient medical records to determine the type of stroke; 2. Patients in the acute phase of stroke (onset <30 days) or with unstable conditions; 3. Those unable to understand the survey content and without a carer to assist; 4. Those not currently receiving any secondary prevention medication for stroke (compliance cannot be assessed); 5. Those with severe mental disorders (e.g. schizophrenia, bipolar disorder) affecting the reliability of self-reports; 6. Those who explicitly refuse to participate in the survey or are uncooperative; Phase Five: Qualitative Interviews on Medication Adherence and Behaviour Exclusion Criteria: 1. Those unable to communicate (severe aphasia, impaired consciousness, severe cognitive impairment); 2. Those with overt psychiatric symptoms or emotional instability that may compromise the safety or quality of the interview; 3. Those who experience distress during the interview (e.g. emotional agitation, marked rise in blood pressure) and whom the investigator deems should be withdrawn; 4. Those unable to provide medication-related experiences or whose information is insufficient to support the interview content (e.g. medication is administered entirely by others and the participant is unaware of the situation); 5. Those who explicitly refuse to participate in the interview or are uncooperative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Internal consistency of Chinese MARS-10/MARS-5 (Cronbach’s a);Structural validity of Chinese MARS-10/MARS-5 (EFA/CFA model fit indices);Criterion validity of Chinese MARS-10/MARS-5;Test–retest reliability of Chinese MARS-10/MARS-5 (ICC); | — |
Countries
China
Contacts
Public ContactJiajun Huang
The Second People’s Hospital of Neijiang
Outcome results
None listed