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Is Osteoporosis Education Effective in Parkinsonian Patients

Primary Purpose

Osteoporosis, Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Providing structured osteoporosis education
Giving informative leaflet
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring osteoporosis, parkinson disease, osteoporosis education, knowledge level, daily life

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Providing structured OP education in addition to the informative leaflet. (The leaflet contained the same information as the OP education program)

Giving only the informative leaflet. (The leaflet contained the same information as the OP education program)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 25, 2020
Last Updated
August 28, 2020
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04536610
Brief Title
Is Osteoporosis Education Effective in Parkinsonian Patients
Official Title
The Effect Of Osteoporosis Education On Osteoporosis Knowledge Level and Daily Life In Parkinsonian Patients, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Parkinson Disease
Keywords
osteoporosis, parkinson disease, osteoporosis education, knowledge level, daily life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Providing structured OP education in addition to the informative leaflet. (The leaflet contained the same information as the OP education program)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Giving only the informative leaflet. (The leaflet contained the same information as the OP education program)
Intervention Type
Behavioral
Intervention Name(s)
Providing structured osteoporosis education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Giving informative leaflet
Intervention Description
Leaflets containe the same information as the OP education program
Primary Outcome Measure Information:
Title
Physical Activity Scale For The Elderly score at the endpoint
Description
(0-763 points) Higher scores mean a better outcome
Time Frame
At 12th week
Title
National Osteoporosis Foundation daily calcium intake scale score at the endpoint
Description
(250mg - ... mg) Higher scores mean a better outcome
Time Frame
At 12th week
Secondary Outcome Measure Information:
Title
Revised 2011 Osteoporosis Knowledge Test score at the endpoint
Description
(0-32 points) Higher scores mean a better outcome
Time Frame
At 12th week
Title
Smoking and alcohol use status at the endpoint
Description
(Yes/No) "No" is a better status
Time Frame
At 12th week
Title
Amount of smoking and alcohol use at the endpoint
Description
(Cigarette pack / per week, alcohol unit / per week). Lower scores mean a better outcome
Time Frame
At 12th week
Title
Frequency of falls at the endpoint
Description
Times / last 1 month
Time Frame
At 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients aged 50 years or older Being diagnosed with Parkinson's Disease Exclusion Criteria: 1. Severe physical and cognitive dysability
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Is Osteoporosis Education Effective in Parkinsonian Patients

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