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Assessment of the benefits of Health Education with educational material for patients with Parkinson's Disease

Assessment of the benefits of a validated educational manual for patients with mild to moderate Parkinson's disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8pqgrpn
Enrollment
Unknown
Registered
2025-05-08
Start date
2024-09-28
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease, Health Literacy, Health Education

Interventions

This is a randomized, double-blind clinical study that will have randomization of patients. "Intervention" group: 40 patients with mild to moderate Parkinson's disease, who will attend 12 weekly meeti

Sponsors

Hospital Universitário Walter Cantídio da Universidade Federal do Ceará
Lead Sponsor
Hospital Universitário Walter Cantídio da Universidade Federal do Ceará
Collaborator

Eligibility

Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: Have a diagnosis of Parkinson's disease according to the Movement Disorders Society criteria; Parkinson's disease stage from 1 to 3, according to the modified Hoehn and Yahr (HY) scale; be literate; Be =40 years old; female or male gender

Exclusion criteria

Exclusion criteria: Diagnosis of multiple sclerosis, acute disseminated encephalomyelitis, parkinsonism plus, cerebrovascular disease with motor sequelae, or Guillain-Barré syndrome; dementia syndrome of any etiology according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); schizophrenia with hospitalization, psychotic episode, or suicidal ideation in the last 6 months; Bipolar affective disorder with hospitalization or episode of mania, hypomania, or depression in the last 6 months; depression with hospitalization, suicidal ideation, or a psychotic episode in the last 6 months; myocardial infarction with or without ST-segment elevation in the last 12 months; myocardial revascularization surgery or percutaneous angioplasty in the last 12 months; uncontrolled arrhythmia; severe chronic obstructive pulmonary disease or oxygen dependency; Heart failure with functional reduction and symptom classification in stage III or IV; resting blood pressure =160 × 100 mmHg; implantable cardioverter-defibrillator; severe chronic kidney disease (creatinine clearance 14 drinks per week; living with individuals participating in the same study; thromboembolism without the use of anticoagulants; significant weight loss (10% of usual weight) in the last 6 months; lack of family support to participate in the study; mini-Mental State Examination (MMSE) score less than 25 for patients with 1 to 4 years of education, less than 27 for patients with 5 to 8 years of education, less than 28 for patients with 9 to 11 years of education, or less than 29 for patients with more than 11 years of education

Design outcomes

Primary

MeasureTime frame
Primary outcome: To evaluate the effect of health education in small weekly groups on quality of life through the assessment of the Parkinson's Disease Questionnaire-39 (PDQ-39);

Secondary

MeasureTime frame
Secondary outcome: To evaluate the effect of health education in small weekly groups on physical performance through the Short Physical Performance Battery (SPPB);;Secondary outcome: To evaluate the effect of health education in small weekly groups on sleep quality through the Pittsburgh Sleep Quality Questionnaire;;Secondary outcome: To evaluate the effect of health education in small weekly groups on the level of physical activity through the International Physical Activity Questionnaire - short;;Secondary outcome: To assess the effect of weekly small-group health education on fear of falling through the Functional Efficacy Scale-International.

Countries

Brazil

Contacts

Public ContactRayane Monteiro

Universidade Federal do Ceará

rayanermonteiro@outlook.com+55(85)3366-8000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)