Self-Management and Exercise Programme Using Mobile Instant Messaging Application for Older Adults Living with Chronic Knee Pain

NCT06708039 | Not Yet Recruiting

• 1 other identifier: IREC 2024-226
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this Cluster Randomised, controlled trial (CRT, with two parallel groups pre- and post-test design) is to evaluate the potential effects of the self-management and exercise programme (SMEP) for older adults living with chronic knee pain which is delivered using mobile instant messaging application. The main questions it aims to answer are:

1. 1.Are there any change in pain, physical function, mental well-being, the risk of fall, health belief and self-efficacy and quality of life after the intervention is carried out at week 5?
2. 2.Are there any significance difference in pain, physical function, mental well-being, the risk of fall, health belief and self-efficacy and quality of life between the experimental and control group at baseline and week 5.
3. 3.What are the factors related to the adherence to programme within 5 weeks it is delivered.
4. 4.What are the factors that facilitates or inhibits the implementation process of the programme

Conditions

Chronic Knee Pain

Keywords

Self-management; Exercise; WhatsApp; Older Adults; Chronic Knee Pain

Outcome Measures

Primary Outcomes (7)

• Change from Baseline in Pain Trough Knee Injury and Osteoarthritis Outcome Score subscales of pain (KOOS-pain) at 5 weeks.

  KOOS-pain - Included nine questions about pain that score on a Likert scale with five answer alternatives ranging from 0 (no problem) to 4 (extreme problem). Each of the five scores is calculate as the sum of the items and scores between 0 and 100 represent the percentage of total possible score achieve. Zero representing extreme knee problems and 100 representing no knee problems

  From enrollment to the end of treatment at 5 weeks

• Change from Baseline in the Physical Function Trough Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales of symptoms (KOOS-symptoms), function in daily living (KOOS-ADL), function in sports and recreation (KOOS-sport/rec) at 5 weeks.

  Another three (3) subscale in KOOS that provide information about the disability impact from knee injury and associated problems on recreational activities and at the same time also it provides a good indicator for physical performance. All items in each subscale contain questions that were scored on a Likert scale of 0 (no problem) to 4 (extreme problem), where subscale symptoms (7 items); ADL Function (17 items); Sport and Recreation Function (5 items). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

  From enrollment to the end of treatment at 5 weeks

• Change from Baseline in Mental Well-being Trough Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) at 5 weeks.

  SWEMWBS is a short version of the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and enable to monitor of mental wellbeing in the general population that is widely used globally. It uses seven of the WEMWBS's 14 statements about thoughts and feelings, which relate more to functioning than feelings and so offer a slightly different perspective on mental wellbeing. A 5-point Likert scale is used, ranging from none of the time (1), to rarely (2), some of the time (3), often (4) and all of the time (5) to indicate the feelings of respondents. The score by summing the scores for all seven items (7-35) before transforming the total score based on the metric score conversion table. Scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing.

  From enrollment to the end of treatment at 5 weeks

• Change from Baseline in Risk of Fall Trough Short Falls Efficacy Scale-International (Short FES-I) at 5 weeks.

  Measures of "fear of falling" or, more properly, "concerns about falling" among participants. It consists of seven items which measure confidence in performing a range of activities of daily living without falling. A 4-point scale is used ranging from no concern (1) about falling to severe concern (4) about falling. The sum of the items ranges from 7 to 28 with cut-off points of low (7-8), medium (9-13), and high (14-28).

  From enrollment to the end of treatment at 5 weeks

• Change from Baseline in Self-efficacy Trough Health beliefs and self-efficacy in exercise questionnaires at 5 weeks.

  Reflect the concepts of beliefs about individuals' ability to perform exercise and self-efficacy. It consists of twenty items which are: self-efficacy for exercise (four items), barriers to exercise (three items), benefits of exercise (five items), and impact of exercise on arthritis (eight items). A 5-point Likert scale is used ranging from 'strongly agree' to 'strongly disagree' to indicate the beliefs of respondents. The total score is calculating by adding together the respondents scores on the subscale and the sum of the items indicates higher scores reflecting greater self-efficacy or firmer belief in exercise.

  From enrollment to the end of treatment at 5 weeks

• Change from Baseline in Quality of Life Trough Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales of quality of life at 5 weeks.

  KOOS subscales of quality of life is specifically focuses on assessing the impact of knee problems on a person's quality of life that includes aspects such as how knee issues affect daily activities, recreational activities, and overall well-being. It consists of four items and every item have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.

  From enrollment to the end of treatment at 5 weeks

• Change from Baseline in Pain Trough 11 Point Numerical Rating Scale (NRS) at 5 weeks.

  1\. NRS - Zero is equivalent to no pain and 10 indicates the worst possible pain.

  From enrollment to the end of treatment at 5 weeks

Study Arms (2)

Mobile Instant Messaging Application based Self-Management and Exercise Programme (SMEP)

EXPERIMENTAL

The experimental group will receive the self-management and exercise programme, which will be delivered using mobile messaging application (WhatsApp), twice per week for five weeks. In addition, the experimental group will also continue their Elderly Day Care Centre routine activities.

Other: Mobile Instant Messaging Application based Self-management and Exercise Programme (SMEP)for Older Adults with Chronic Knee Pain.

Control Group

NO INTERVENTION

The control group will continue their PAWE routine activities only

Interventions

Mobile Instant Messaging Application based Self-management and Exercise Programme (SMEP)for Older Adults with Chronic Knee Pain. OTHER

The Mobile Instant Messaging Application based self-management and exercise programme (SMEP) consists of 10 short videos of self-management on chronic knee pain in older adults (5-10 minutes/video), 10 short videos of exercise interventions (5-10 minutes/video) and group discussions (10-20 minutes/session) with each video/session focusing on different content. A WhatsApp group that includes all participants in the intervention group will be created to deliver the three components of the program twice a week for five weeks. At the end of each session, they will be given the power point slides from the self-management video in Pdf format and an e-pamphlet of the exercise video. A total of 30-40 minutes will be allocated for each session to allow for socialization between the participants and researcher and also for a question and answer session.

Mobile Instant Messaging Application based Self-Management and Exercise Programme (SMEP)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report of having the pain for more than 6 months.
• Able to meet programme requirement - screening via KNEST and PAR-Q.
• Owning a smartphone, tablet, or computer with an internet connection and WhatsApp application; and being able to use the device without assistance.
• Independently mobile either with or without a walking aid.
• Able to communicate in Malay.
• Able to read and write in Malay.

You may not qualify if:

• Knee replacement / lower limb arthroplasty.
• Intraarticular injections within the past six months.
• Significant musculoskeletal issues (e.g. inflammatory arthritis, connective tissue diseases, fibromyalgia, severe osteoporosis, peripheral neuropathy, or gout).
• Unstable medical or psychiatric conditions.
• Severe cognitive, auditory or visual impairment.

Sponsors & Collaborators

• International Islamic University Malaysia: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Suliza binti Sulaiman

CONTACT

(+6012)9170381; suliza.bal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The experimental group will receive the self-management and exercise programme, which will be delivered using mobile messaging application (WhatsApp), twice per week for five weeks. In addition, the experimental group will also continue their Elderly Day Care Centre routine activities. On the other hand, the control group will continue their Elderly Day Care Centre routine activities only.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 27, 2024
• Study Start: November 18, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share