- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04047069
The Effect of Occupational Therapy Intervention in Hemodialysis Patients
August 3, 2019 updated by: Özgü İNAL, Hacettepe University
The Effect of Person-Centered Occupational Therapy Intervention on Occupational Performance and Quality of Life in Hemodialysis Patients
The aim of this study is to investigate the effect of person-centre occupational therapy intervention on activity performance and quality of life in hemodialysis patients.
The results of the study will guide the intervention programs for prevention, coping and improving the quality of life of HD patients.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Edirne, Turkey, 22100
- Özgü İnal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosed as chronic renal failure.
- between 18-65 years
- undergoing HD treatment for at least 1 year
Exclusion Criteria:
- Beck Depression Scale score of 17 or higher
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
Awareness Training
|
Exp.
|
|
Experimental: Intervention group
|
Exp. identifying the activities the person wants to do, suggestions to facilitate the activity, arranging the activity according to the needs of the person, arranging the environment so that the environment can be a facilitating factor in the activities the person wants to do.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life (with a quality of life scale specific to renal patients).
Time Frame: 1st day of study
|
The KidneyDisease Quality of Life (KDQOL-36) consists of the SF-12, which measures physical and mental functioning, Burden of Kidney Disease subscale, Symptoms and Problems subscale, and Effects of Kidney Disease on Daily Life subscale.
The scores of theKDQOL-36 questionnaire are transformed into 0 to 100, with higherscores indicating better quality of life.combines the generic SF-36 Health Survey instrument and disease-specific components for assessing the health-related quality of life of
|
1st day of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Anticipated)
August 12, 2019
Study Completion (Anticipated)
October 30, 2019
Study Registration Dates
First Submitted
August 1, 2019
First Submitted That Met QC Criteria
August 3, 2019
First Posted (Actual)
August 6, 2019
Study Record Updates
Last Update Posted (Actual)
August 6, 2019
Last Update Submitted That Met QC Criteria
August 3, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2019/257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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