NCT04816474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

April 7, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

March 11, 2021

Last Update Submit

March 29, 2022

Conditions

Keywords

Osteoarthritisnurseself-efficacyquality of lifefunctional status

Outcome Measures

Primary Outcomes (1)

  • 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.

    [Baseline, 6 weeks and 12 weeks]

Secondary Outcomes (1)

  • Change from baseline in self-efficacy at 6 weeks and 12. weeks.

    [Baseline, 6 weeks and 12 weeks]

Other Outcomes (1)

  • Change from baseline in life quality at 6 weeks and 12. weeks.

    [Baseline, 6 weeks and 12 weeks]

Study Arms (2)

Education and Phone Counseling Service

EXPERIMENTAL

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.

Behavioral: Online education and Phone Counseling Service

Control

NO INTERVENTION

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

Interventions

Online education total of 6 times for 6 weeks. Phone Counseling Service total of 6 times for 6 weeks

Education and Phone Counseling Service

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akademi Hastanesi

Konya, 42000, Turkey (Türkiye)

Location

Konya Meram Akademi Hastanesi

Konya, 42020, Turkey (Türkiye)

Location

Related Publications (1)

  • Yilmaz E, Polat U. Online Disease Management Training for Older Adults With Osteoarthritis: A Randomized Controlled Trial. Musculoskeletal Care. 2024 Sep;22(3):e1931. doi: 10.1002/msc.1931.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 25, 2021

Study Start

August 10, 2021

Primary Completion

October 10, 2021

Study Completion

January 10, 2022

Last Updated

April 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

After the research is completed.

Locations