Is Osteoporosis Education Effective in Parkinsonian Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Osteoporosis
• Intervention / Treatment: Behavioral: Providing structured osteoporosis education; Behavioral: Giving informative leaflet

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Dokuz Eylül University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Providing structured OP education in addition to the informative leaflet. (The leaflet contained the same information as the OP education program)	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.; Behavioral: Giving informative leaflet; Leaflets containe the same information as the OP education program
Active Comparator: Control group; Giving only the informative leaflet. (The leaflet contained the same information as the OP education program)	Behavioral: Giving informative leaflet; Leaflets containe the same information as the OP education program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised 2011 Osteoporosis Knowledge Test score at the endpoint	(0-32 points) Higher scores mean a better outcome	At 12th week
Smoking and alcohol use status at the endpoint	(Yes/No) "No" is a better status	At 12th week
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
Frequency of falls at the endpoint	Times / last 1 month	At 12th week

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: osteoporosis; parkinson disease; knowledge level; osteoporosis education; daily life
• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Bone Diseases; Bone Diseases, Metabolic; Parkinson Disease; Osteoporosis
• Other Study ID Numbers: Kerim OP Parkinson

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No