- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04816474
The Effects of Disease Management Training and Telephone Counseling Service for Elderly Patients With Osteoarthritis
March 29, 2022 updated by: KTO Karatay University
The Effect of Training on Disease Management and Phone Counseling Service for Older Patients With Osteoarthritis on Functional Status, Self-Efficacy and Quality of Life
The study will be conducted to determine the difference on functional status, self-efficacy, and quality of life between groups with and without telephone counseling and training on disease management for participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
When the literature is examined, in patients with osteoarthritis who receive face-to-face training and intermittent telephone counseling; It is observed that the level of self-efficacy, compliance with the disease and quality of life have increased.
It is stated that face-to-face training and telephone counseling services provided to participants on disease management will increase the effectiveness of education and as a result; It is thought that participants may have positive outcomes such as expressing their problems more easily, feeling safer by communicating frequently, and developing methods of coping with nurse-patient cooperation.
When the studies conducted in our country are examined, while there are studies examining the effect of non-pharmacological interventions such as acupressor, hot-cold application, exercise training, mud pack treatment in patients with osteoarthritis; No study was found in the elderly patient group in which education and telephone counseling were conducted.
The results of the research are thought to be beneficial in managing the disease in addition to in addition to pharmacological treatment.
Study Type
Interventional
Enrollment (Actual)
52
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
-
-
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Konya, Turkey, 42000
- Akademi Hastanesi
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Konya, Turkey, 42020
- Konya Meram Akademi Hastanesi
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 65 and over
- OA was diagnosed by the physician according to the American College of Rheumatology (ARD) criteria,
- Being able to answer research questions
- Individuals who gave their oral and written consent to participate in the study were included.
Exclusion Criteria:
- Having a history of malignancy
- Those who score above 5 points from the Visual Analogue Scale
- With a neuro psychiatric illness
- Having vision and hearing problems
- Receiving intraarticular medication (steroid, chondramine, hyaluronic acid) in the last month
- Surgery applied to the knee joint in the last 3 months
- Having inflammation in the joints
- Have an open wound in the OA area
- Individuals with a diagnosed vascular disease will not be included.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education and Phone Counseling Service
Patients in this group will be trained online for 6 weeks.
After the online training is over, a telephone consultation service will be provided once a week for 6 weeks.
|
Online education total of 6 times for 6 weeks.
Phone Counseling Service total of 6 times for 6 weeks
|
|
No Intervention: Control
No application will be made to patients in this group for 12 weeks.
Pre-test and post-test will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in functional status at 6 weeks and 12. weeks.
Time Frame: [Baseline, 6 weeks and 12 weeks]
|
After the training and counseling, the functional status scores of the patients are checked.
The Western 45 Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale has undergone several revisions.
WOMAC; It consists of three subgroups: pain during various positions and movements, severity of joint stiffness, and difficulty in performing daily life activities.
A total of 24 questions (pain 5, joint stiffness 2, physical function 17) and 5-point likert.
In the evaluation, the questions are scored between 0 and 4 according to the Likert scale.
The first option "no pain" is calculated as 0 points, the last option "very severe pain" is calculated as 4 points.
Maximum scores of subgroups; 20 for pain, 8 for joint stiffness and 68 for physical function.
The total score for each subgroup is the sum of the scores given to each item.
As the scores get higher, symptoms worsen, restriction increases, and general health deteriorates.
|
[Baseline, 6 weeks and 12 weeks]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in self-efficacy at 6 weeks and 12. weeks.
Time Frame: [Baseline, 6 weeks and 12 weeks]
|
After the interventions, the patient's self-efficacy scores are checked.
Self-Efficacy Scale in Arthritis; It consists of 20 expressions evaluated on a visual scale with 10 digits, whose starting point is "I'm not sure = 1" and the other end is "I'm very sure = 10".
It has four sub-dimensions: self-efficacy pain, self-efficacy hand and arm functions, self-efficacy foot leg functions and self-efficacy other symptoms.
The first five statements are included in the self-efficacy pain sub-dimension and determine the level of pain coping in arthritis patients.
The next nine statements are named self-efficacy hand-arm functions and self-efficacy foot leg functions, and are the two sub-dimensions of self-efficacy functions in the original.
The minimum score of the scale is 20 and the maximum score is 200, and the higher the score is the indicator of the higher self-efficacy level.
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[Baseline, 6 weeks and 12 weeks]
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in life quality at 6 weeks and 12. weeks.
Time Frame: [Baseline, 6 weeks and 12 weeks]
|
After the interventions, the patient's life quality scores are checked.
The World Health Organization Quality of Life Scale Elderly Module, the older module of World Health Organization Quality of Life Scale, Bullinger et al. developed by.
The World Health Organization Quality of Life Scale Elderly Module consists of 24 questions in six dimensions where the answers are determined with a five-point Likert scale.
These six dimensions are: "sensory functions" (questions 1, 2, 10 and 20), "Autonomy" (questions 3, 4, 5 and 11), "Past, Present, Future Activities" (12, 13, 15).
and questions 19), "Social participation" (questions 14,16, 17 and 18), "death and dying" (questions 6, 7, 8 and 9) and "Intimacy" (questions 21, 22, 23 and 24).
questions).
Possible dimension scores range from 4-20.
Also, the "total score" can be calculated by adding up the individual point values.
The higher the score, the better the quality of life.
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[Baseline, 6 weeks and 12 weeks]
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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)
August 10, 2021
Primary Completion (Actual)
October 10, 2021
Study Completion (Actual)
January 10, 2022
Study Registration Dates
First Submitted
March 11, 2021
First Submitted That Met QC Criteria
March 24, 2021
First Posted (Actual)
March 25, 2021
Study Record Updates
Last Update Posted (Actual)
April 7, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KTO Karatay University Evre
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
After the research is completed.
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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