Self-Management and Exercise Programme Using Mobile Instant Messaging Application for Older Adults Living with Chronic Knee Pain.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 82
- Primary Endpoint
- Change from Baseline in Pain Trough Knee Injury and Osteoarthritis Outcome Score subscales of pain (KOOS-pain) at 5 weeks.
Study Overview
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:
- 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?
- 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.
- What are the factors related to the adherence to programme within 5 weeks it is delivered.
- What are the factors that facilitates or inhibits the implementation process of the programme
Selected clusters will be randomized into either experimental or control group. The experimental group will receive the self-management and exercise programme, which will be delivered using mobile messaging application, 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
Detailed Description
3.1 Study Type and Design A cluster randomized controlled trial (CRT) with two parallel groups (experimental vs control) pre- and post-test design will be utilized to conduct this study. Four clusters of Elderly Day Care Centre will participate in this study, where each two will be randomized into either experimental or control group by using a computer generated table of random numbers by a person external to the study. The experimental group will receive WhatsApp-based self-management and exercise programme (SMEP) twice per week for five weeks in addition to Elderly Day Care Centre routine activities that they normally receive. On the other hand, the control group will continue the routine activities only. The routine activities in Elderly Day Care Centre include the medical care (pharmacological and non-pharmacological treatment) prescribed by their healthcare professionals, various programmes (E.g. religion, recreation, therapy, rehabilitation and health talk programme) and appropriate training or courses.
At first appointment, both groups will receive an educational session by the researcher that explain briefly about the programme, anatomical of the knee, chronic knee pain, risk factors of knee pain, management of knee pain, self-management and exercise as a treatment, recommended exercise and pain management techniques in a two-hour educational session. In addition to the first educational session at the Elderly Day Care Centre, participants in the intervention group will receive all the self-management and exercise content through the mobile instant messaging application (WhatsApp). However, participants allocated to the control group will be given the component of the programme after finishing the study (after 5 weeks).
The researcher will only meet the participants once at the beginning of the study. Data on demographics, clinical, Knee Pain Scoring Tools (KNEST) and Physical Activity Readiness Questionnaire for Everyone (PAR-Q) will be collected directly from the participants from both groups at the beginning of the study. All outcome measures will be measure before the initiation of the program (baseline), and then measured again at five weeks of training (post-training). Questionnaires in Malay will be used to measure pain, physical function, mental well-being, the risk of fall, health belief and self-efficacy and quality of life.
The SMEP will be develop by findings from the systematic literature reviews and relevant evidence based including theory that support choices for the intervention content. The development of the programme will be guided by the UK MRC framework. The programme were developed and adopted based on previous studies that had showed the significance effect of that particular programme . However, this programme is more focusing on the management of chronic knee pain for older people.
This programme consists of 10 short videos of self-management on chronic knee pain in elderly (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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Mobile Instant Messaging Application based Self-Management and Exercise Programme (SMEP)
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.
Intervention: Mobile Instant Messaging Application based Self-management and Exercise Programme (SMEP)for Older Adults with Chronic Knee Pain. (Other)
Control Group
The control group will continue their PAWE routine activities only
Outcomes
Primary Outcomes
Change from Baseline in Pain Trough Knee Injury and Osteoarthritis Outcome Score subscales of pain (KOOS-pain) at 5 weeks.
Time Frame: From enrollment to the end of treatment 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
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.
Time Frame: From enrollment to the end of treatment 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.
Change from Baseline in Mental Well-being Trough Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) at 5 weeks.
Time Frame: From enrollment to the end of treatment 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.
Change from Baseline in Risk of Fall Trough Short Falls Efficacy Scale-International (Short FES-I) at 5 weeks.
Time Frame: From enrollment to the end of treatment 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).
Change from Baseline in Self-efficacy Trough Health beliefs and self-efficacy in exercise questionnaires at 5 weeks.
Time Frame: From enrollment to the end of treatment 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.
Change from Baseline in Quality of Life Trough Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales of quality of life at 5 weeks.
Time Frame: From enrollment to the end of treatment 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.
Change from Baseline in Pain Trough 11 Point Numerical Rating Scale (NRS) at 5 weeks.
Time Frame: From enrollment to the end of treatment at 5 weeks
1. NRS - Zero is equivalent to no pain and 10 indicates the worst possible pain.
Secondary Outcomes
No secondary outcomes reported
Investigators
Suliza binti Sulaiman
Principal Investigator
International Islamic University Malaysia