Is Osteoporosis Education Effective in Parkinsonian Patients

Parkinson Disease Clinical Trial

Official title:

The Effect Of Osteoporosis Education On Osteoporosis Knowledge Level and Daily Life In Parkinsonian Patients, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536610
• Other study ID #: Kerim OP Parkinson
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: August 2020
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Parkinson Disease

Intervention

Behavioral:
• Providing structured osteoporosis education
The OP education was performed in groups of 4-5 people by a single physician with a single session in the form of verbal expression via slide, with a duration of 20 minutes.
• Giving informative leaflet
Leaflets containe the same information as the OP education program

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Scale For The Elderly score at the endpoint	(0-763 points) Higher scores mean a better outcome	At 12th week
Primary	National Osteoporosis Foundation daily calcium intake scale score at the endpoint	(250mg - ... mg) Higher scores mean a better outcome	At 12th week
Secondary	Revised 2011 Osteoporosis Knowledge Test score at the endpoint	(0-32 points) Higher scores mean a better outcome	At 12th week
Secondary	Smoking and alcohol use status at the endpoint	(Yes/No) "No" is a better status	At 12th week
Secondary	Amount of smoking and alcohol use at the endpoint	(Cigarette pack / per week, alcohol unit / per week). Lower scores mean a better outcome	At 12th week
Secondary	Frequency of falls at the endpoint	Times / last 1 month	At 12th week