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The Effects of Disease Management Training and Telephone Counseling Service for Elderly Patients With Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Online education and Phone Counseling Service
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Osteoarthritis, nurse, self-efficacy, quality of life, functional status

Eligibility Criteria

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

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.

Sites / Locations

  • Akademi Hastanesi
  • Konya Meram Akademi Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education and Phone Counseling Service

Control

Arm Description

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.

No application will be made to patients in this group for 12 weeks. Pre-test and post-test will be applied.

Outcomes

Primary Outcome Measures

Change from baseline in functional status at 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.

Secondary Outcome Measures

Change from baseline in self-efficacy at 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.

Full Information

First Posted
March 11, 2021
Last Updated
March 29, 2022
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT04816474
Brief Title
The Effects of Disease Management Training and Telephone Counseling Service for Elderly Patients With Osteoarthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
October 10, 2021 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, nurse, self-efficacy, quality of life, functional status

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education and Phone Counseling Service
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No application will be made to patients in this group for 12 weeks. Pre-test and post-test will be applied.
Intervention Type
Behavioral
Intervention Name(s)
Online education and Phone Counseling Service
Intervention Description
Online education total of 6 times for 6 weeks. Phone Counseling Service total of 6 times for 6 weeks
Primary Outcome Measure Information:
Title
Change from baseline in functional status at 6 weeks and 12. weeks.
Description
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.
Time Frame
[Baseline, 6 weeks and 12 weeks]
Secondary Outcome Measure Information:
Title
Change from baseline in self-efficacy at 6 weeks and 12. weeks.
Description
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.
Time Frame
[Baseline, 6 weeks and 12 weeks]
Other Pre-specified Outcome Measures:
Title
Change from baseline in life quality at 6 weeks and 12. weeks.
Description
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.
Time Frame
[Baseline, 6 weeks and 12 weeks]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Akademi Hastanesi
City
Konya
ZIP/Postal Code
42000
Country
Turkey
Facility Name
Konya Meram Akademi Hastanesi
City
Konya
ZIP/Postal Code
42020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After the research is completed.

Learn more about this trial

The Effects of Disease Management Training and Telephone Counseling Service for Elderly Patients With Osteoarthritis

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