Is Osteoporosis Education Effective in Parkinsonian Patients

Not Applicable

Completed

• Conditions: Osteoporosis; Parkinson Disease
• Interventions: Behavioral: Giving informative leaflet; Behavioral: Providing structured osteoporosis education

• Registration Number: NCT04536610
• Lead Sponsor: Dokuz Eylul University

Brief Summary

The effects of osteoporosis (OP) education on OP patients and the normal population studied and described in numerous studies. But the effects of OP education on Parkinsonian patients have not been sufficiently elucidated.

The purpose of this study was to evaluate the effect of OP education on the OP knowledge level and daily life in Parkinsonian patients.

Our hypothesis is; to Parkinsonian patients; there is a statistically significant difference in terms of OP knowledge level and daily life between giving only informative leaflets about OP and also providing structured OP education.

54 participants aged 50 and older with Parkinson's Disease were randomized to the experimental and control groups. While only leaflets were given to the control group, structured OP education was also given to the experimental group. Patients were evaluated with the same structured face-to-face interviews at the entrance and 12 weeks later.

Detailed Description

The OP education was performed in groups of 4-5 people by a single physician in the form of verbal expression via slide, with a duration of 20 minutes and in the form of a single session. Our leaflets contained the same information as the OP education program.

Face-to-face interviews include; Revised 2011 Osteoporosis Knowledge Test (rOKT) (0-32 points) for OP knowledge levels; National Osteoporosis Foundation daily calcium intake scale \[NOF, (mg)\], Physical Activity Scale For The Elderly (PASE, 0-763 points), smoking and alcohol use status (Yes/No) and quantities (cigarette pack/per week, alcohol unit/per week), frequency of falls (times/last 1 month) were questioned for effects on daily life.

Study Timeline

• Study Start: 2019-05-20
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-28
• Last Update Submitted: 2020-08-28
• Study First Posted: 2020-09-02
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Male and female patients aged 50 years or older
2. Being diagnosed with Parkinson's Disease

Exclusion Criteria

1. Severe physical and cognitive dysability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Giving informative leaflet	Giving only the informative leaflet. (The leaflet contained the same information as the OP education program)
Experimental group	Providing structured osteoporosis education	Providing structured OP education in addition to the informative leaflet. (The leaflet contained the same information as the OP education program)
Experimental group	Giving informative leaflet	Providing structured OP education in addition to the informative leaflet. (The leaflet contained the same information as the OP education program)

Primary Outcome Measures

Name	Time	Method
Physical Activity Scale For The Elderly score at the endpoint	At 12th week	(0-763 points) Higher scores mean a better outcome
National Osteoporosis Foundation daily calcium intake scale score at the endpoint	At 12th week	(250mg - ... mg) Higher scores mean a better outcome

Secondary Outcome Measures

Name	Time	Method
Revised 2011 Osteoporosis Knowledge Test score at the endpoint	At 12th week	(0-32 points) Higher scores mean a better outcome
Smoking and alcohol use status at the endpoint	At 12th week	(Yes/No) "No" is a better status
Amount of smoking and alcohol use at the endpoint	At 12th week	(Cigarette pack / per week, alcohol unit / per week). Lower scores mean a better outcome
Frequency of falls at the endpoint	At 12th week	Times / last 1 month

Trial Locations

Locations (1)

Dokuz Eylul University; 🇹🇷 İzmir, Turkey