E-Health Lifestyle Intervention for Arthritis: A Pilot RCT on Feasibility

Adherence and follow-up rate

Adherence rate is defined as the proportion of participants following the study protocol: Using the smartband with Smartband+App and using Smartband+App on\> 70% of days are the predefined outcomes for adherence. Research Assistant/social worker will meet weekly with participants in both groups till study-end due to potential technological unfamiliarity of South Asians to troubleshoot usage problems, retrieve data simultaneously, and avoid misusing the smartband. This shall have the highest guarantee of adherence accuracy. Follow-up rate is defined is proportion of participants completing the study at 10 months (study end), with ≥ 70% as the predefined outcome. Achieving ≥ 70% for both rates is a predefined outcome that would enable scale-up to a larger project. Participants are free to drop out at any time point.

Intervention program and assessment acceptability

Acceptability was measured by the Client Satisfaction Questionnaire (CSQ) post-treatment as in similar OA programs (38). The CSQ is commonly used in treatment acceptability studies and includes items such as "How satisfied are you with the amount of help you received?" and "To what degree did the program teach you skills that are helping you to better manage your symptoms?" rated on a Likert scale. The assessment acceptability is also quantitatively assessed by a 5-point Likert questionnaire. ≥70% of participants rating the intervention and assessment as "acceptable" (i.e.,≥4/5 on the Likert scale) as the predefined threshold. Semi-structured interviews at study end will be conducted to capture feedback qualitatively

Recruitment rate

Ratio between the number of eligible participants recruited and the duration of recruitment period (per month). This will help estimate the recruitment time required for full trial.

Performance-Based Functional Limitation Assessed by Gait Speed

Gait speed will be measured using the 6-metre walk test. Participants will be instructed to walk at their usual pace over a 6-metre course, and the faster of two trials will be recorded in metres per second (m/s). A gait speed of less than 1.0 m/s is defined as the threshold for persistent limitations in functioning and mortality, based on previous studies.

Self-Reported Functional Limitation Assessed by Western Ontario and McMaster Universities Osteoarthritis Index Physical Function Subscale

Physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscale. This subscale consists of 17 items assessing difficulty experienced during daily activities such as walking, stair climbing, and rising from a seated position. Each item is scored on a 0-4 Likert scale (0 = none, 4 = extreme), with a total subscale score ranging from 0 to 68 (higher scores indicating worse physical function). A score of 28 or above (≥28/68) is defined as poor functional outcome in previous studies.

Pain Intensity Assessed by the Numerical Pain Rating Scale

Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will be asked to rate their current knee pain intensity. The NPRS is a validated and widely used instrument for assessing pain in patients with knee osteoarthritis.

Pain Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale

Pain will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. This subscale consists of 5 items assessing pain experienced during activities such as walking, using stairs, and resting. Each item is scored on a 0-4 Likert scale (0 = none, 4 = extreme), with a total subscale score ranging from 0 to 20 (higher scores indicating worse pain). The WOMAC pain subscale is a validated and widely used instrument in knee osteoarthritis research.