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Trial registered on ANZCTR


Registration number
ACTRN12621000959875
Ethics application status
Approved
Date submitted
5/04/2020
Date registered
22/07/2021
Date last updated
22/07/2021
Date data sharing statement initially provided
22/07/2021
Date results provided
22/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapeutic Self-Management Education Programme for Older Adults with Knee Osteoarthritis
Scientific title
Self-Management Education Programme on knee Injury and Osteoarthritis Outcome Score and physical functions for Older Adults with Knee Osteoarthritis: A One Group Pretest and Post Test Study
Secondary ID [1] 300952 0
None
Universal Trial Number (UTN)
Trial acronym
SMEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 316971 0
Condition category
Condition code
Musculoskeletal 315124 315124 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 318446 318446 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An educational intervention known as "Therapeutic Self-Management Education Programme" was delivered to older adults who had been diagnosed with knee osteoarthritis. The programme had four sessions lasting between 1 1/2 hours to 2 hours each.
- Printed educational materials such as knee osteoarthritis booklet and exercises pamphlets were used in the educational programme. The 'knee osteoarthritis booklet and exercises pamphlets' were designed specifically for this study which was based on Malaysian cultural population.
- Mode of delivery: Face to face lecture sessions provided in a group of a maximum of 12 participants.
- Setting: The intervention was delivered in the institutional/university club house.
- Overall duration was about 8 hours in which 1 session per week for 4 weeks. Maximum hour for each session was about 2 hours.
- Strategies that were used to retain participants adherence to the intervention include sending notification to participants one day or two days earlier from the intervention day, providing meals after the session and offering transportation expenditure. Some of these strategies had been implemented in previous SMEP studies.
Intervention code [1] 317270 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323402 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 323402 0
The outcome was taken at the baseline (prior the intervention) and 6 weeks after the baseline.
Secondary outcome [1] 381800 0
30 seconds sit to stand test
Timepoint [1] 381800 0
The outcome was taken at the baseline (prior the intervention) and 6 weeks after the baseline.
Secondary outcome [2] 391386 0
Time up and go test
Timepoint [2] 391386 0
The outcome was taken at the baseline (prior the intervention) and 6 weeks after the baseline.
Secondary outcome [3] 391387 0
Chair sit and reach test
Timepoint [3] 391387 0
The outcome was taken at the baseline (prior the intervention) and 6 weeks after the baseline.
Secondary outcome [4] 391388 0
Back scratch test
Timepoint [4] 391388 0
The outcome was taken at the baseline (prior the intervention) and 6 weeks after the baseline.
Secondary outcome [5] 391389 0
Handgrip strength test
Timepoint [5] 391389 0
The outcome was taken at the baseline (prior the intervention) and 6 weeks after the baseline.
Secondary outcome [6] 391390 0
Two-minute walk test
Timepoint [6] 391390 0
The outcome was taken at the baseline (prior the intervention) and 6 weeks after the baseline.

Eligibility
Key inclusion criteria
1) Malaysian
2) 60 years and above
3) Bilateral or unilateral KOA
4) Had been diagnosed with KOA
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Poor grasp of either Malay or English language
2) Any confirmed or suspected serious pathology (fracture less than one year, metastasis, inflammatory or infective disease, and central or pheripheral neurological disorders)
3) History of hip or knee replacement
4) Planned for any surgery within 3 months
5) Had corticosteroid injection less than three months
6) Had other type of arthritis on the lower limbs
7) Still involves in other research studies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/03/2019
Date of last participant enrolment
Anticipated
Actual
21/03/2019
Date of last data collection
Anticipated
Actual
3/05/2019
Sample size
Target
32
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 22469 0
Malaysia
State/province [1] 22469 0
Petaling Jaya, Selangor

Funding & Sponsors
Funding source category [1] 305392 0
Self funded/Unfunded
Name [1] 305392 0
Siti Salwana Kamsan
Country [1] 305392 0
Malaysia
Primary sponsor type
Individual
Name
Siti Salwana Kamsan
Address
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 305774 0
Individual
Name [1] 305774 0
Assoc. Prof. Dr. Devinder Kaur Ajit Singh
Address [1] 305774 0
Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country [1] 305774 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305721 0
University Kebangsaan Malaysia Research Ethics Committee
Ethics committee address [1] 305721 0
Ethics committee country [1] 305721 0
Malaysia
Date submitted for ethics approval [1] 305721 0
15/03/2018
Approval date [1] 305721 0
20/04/2018
Ethics approval number [1] 305721 0
NN-2018-106

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101350 0
A/Prof Devinder Kaur Ajit Singh
Address 101350 0
Jabatan Fisioterapi, Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 101350 0
Malaysia
Phone 101350 0
+639289 7602
Fax 101350 0
Email 101350 0
devinder@ukm.edu.my
Contact person for public queries
Name 101351 0
Siti Salwana Kamsan
Address 101351 0
Department of Physical Rehabilitation Sciences, Kulliyyah of Allied Health Sciences, International Islamic University Malaysia, 25200 Kuantan Pahang, Malaysia.
Country 101351 0
Malaysia
Phone 101351 0
+6192575560
Fax 101351 0
Email 101351 0
sitisalwana@iium.edu.my
Contact person for scientific queries
Name 101352 0
Siti Salwana Kamsan
Address 101352 0
Department of Physical Rehabilitation Sciences, Kulliyyah of Allied Health Sciences, International Islamic University Malaysia, 25200 Kuantan Pahang, Malaysia.
Country 101352 0
Malaysia
Phone 101352 0
+6192575560
Fax 101352 0
Email 101352 0
sitisalwana@iium.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality concerns.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.