An Implementation Science Approach to Evaluating Self-Administered Acupressure for Knee Osteoarthritis in Older-Aged Adults in the Community

Knee OA is a prevalent and debilitating condition in older adults, often managed with medications that have side effects or nonpharmacological interventions requiring significant behavioral change. Acupressure, a variant of acupuncture, can be self-administered after appropriate training and has shown efficacy in previous RCTs for knee OA. This study will implement the SAA program in district elderly community (DEC) centers across Hong Kong, training frontline workers and older adults to deliver and practice acupressure. The intervention includes two training sessions, ongoing support, and a 24-week follow-up. Effectiveness will be measured by pain reduction, improved knee function, and quality of life, while implementation outcomes will be evaluated using the RE-AIM framework. Qualitative interviews will explore facilitators and barriers to adoption and sustainability.

Objectives:

1. To explore the reach, adoption, implementation, and maintenance of the SAA program among community service units. 2. To examine the effectiveness of the SAA program in relieving pain and improving knee function in middle-aged and older adults in real-world settings. 3. To explore the experiences (facilitators and barriers) of adopting SAA in routine services through qualitative interviews.

Hypothesis

* The SAA program will be effectively implemented in community settings, achieving high reach, adoption, fidelity, and sustainability. * Participants in the SAA group will experience greater reductions in knee pain and improvements in knee function and quality of life compared to the control group.

Design and subjects:

* Design: Pragmatic cluster randomized controlled trial (RCT) with mixed-methods (quantitative and qualitative). * Setting: District Elderly Community (DEC) centers in Hong Kong. * Subjects:

* Sample Size: 368 older adults (aged ≥60), recruited from DEC centers (8 clusters per group, 23 participants per cluster). * Inclusion Criteria: Ethnic Chinese, aged ≥60, able to read Chinese and comprehend Mandarin/Cantonese, probable knee OA (based on clinical criteria), knee pain ≥3 months, pain score ≥3/10, smartphone access, consent. * Exclusion Criteria: Medical conditions precluding participation, knee pain from other causes, cognitive impairment, BMI \>30, prior knee replacement.

Interventions:

* SAA Group (Focus Group):

* Two acupressure training sessions (2 hours each, 1 week apart) led by trained instructors. * Training includes acupressure technique, knee-health education, practice with feedback, and provision of materials (handouts, rods, logbook). * Daily home practice (morning and night) for 24 weeks, with ongoing support via WhatsApp and phone calls. * General Health Education Group (Control Group):

* A general health education booklet will be provided during the study period; will receive the SAA program after 24-week outcome evaluation.

Main outcome measures:

The outcome measures will include treatment effectiveness and implementation.

Effectiveness Outcome Primary outcome measure is the numerical rating scale for knee pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Short-Form Six-Dimension (SF-6D), Timed Up \& Go Test (TUG) and Fast Gait Speed (FGS).

Implementation Outcome RE-AIM framework will be used to evaluate the project, which covers five aspects of reach, effectiveness, adoption, implementation, and maintenance.

Data Analysis

* Quantitative:

* Double data entry; analysis in SPSS 28.0. * Baseline differences controlled as covariates. * Linear mixed-effect models to compare changes in primary (NRS pain score) and secondary outcomes (WOMAC, SF-6D, functional tests) over time. * Compliance and clinical significance assessed (≥2-point or ≥30% reduction in NRS). * Intention-to-treat analysis. * Qualitative:

* Thematic content analysis of interview transcripts using NVivo 12.0. * Open coding by two independent researchers; themes reviewed for sufficiency and coherence. * Cost-Effectiveness:

* QALYs calculated from SF-6D. * Incremental cost-effectiveness ratio (ICER) computed. * Bootstrapping (5,000 iterations) for uncertainty; cost-effectiveness acceptability curve generated.

• Western Ontario and McMaster University Osteoarthritis Index [Срок оценки: Baseline, Week 4, Week 12, Week 24]
• Short Form 6D (SF-6D) [Срок оценки: Baseline, Week 4, Week 12, Week 24]
• Timed Up and Go Test [Срок оценки: Baseline, Week 4, Week 12, Week 24]
• Fast Gait Speed test [Срок оценки: Baseline, Week 4, Week 12, Week 24]
• Analgesic Usage [Срок оценки: Baseline, Week 4, Week 12, Week 24]
• Compliance Assessment [Срок оценки: Baseline, Week 4, Week 12, Week 24]