| Protocol ID | NCT05634304 |
| Registration Date | 2022-12-02 |
| Status | Unknown Status |
| Sponsor | Chang Gung Memorial Hospital |
| Country | Taiwan |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2019-08-01 |
| Last Patient Out | 2023-07-31 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 45 Years - |
NCT05634304
MyOsteoarthritisMyWay: Needs Exploring, Program Developing, and Implementing of a Patient-Centered Mobile App Self-Management Program for Osteoarthritis
| Field |
GLM
glm-5.1 7033ms / 10288 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5606ms / 11665 tok |
OPENAI
gpt-4o Thinking: o3 3623ms / 10130 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient |
outpatient
outpatient → mixed
shaky reasoning✗ No consensus
Initial: outpatient
Requery: mixed — Patients are recruited from an orthopedics clinic (outpatient) and the baseline data is explicitly collected at 'pre-discharge hospital' (inpatient), indicating the study spans both admission and post-discharge phases over the 6-month intervention.
|
outpatient
outpatient → outpatient → outpatient
shaky reasoning✗ No consensus
Initial: outpatient
Requery: outpatient — The study recruits patients from an orthopedics clinic and delivers a mobile app self-management program that patients use at home over 6 months, with follow-up visits at 1, 3, and 6 months.
Thinking: outpatient — The intervention is a mobile app self-management program that patients use at home over 6 months after recruitment from an orthopedics clinic.
|
mixed
mixed → outpatient → mixed
shaky reasoning✗ No consensus
Initial: mixed
Requery: outpatient — The intervention involves the use of a mobile app self-management program, which is typically conducted in an outpatient setting where patients are not hospitalized.
Thinking: mixed — The program starts with patients still hospitalized (baseline pre-discharge) and then continues for months after discharge in the community, involving both inpatient and outpatient phases.
|
|
| setting_place |
other
other
shaky reasoning✓ Unanimous
Initial: other
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The mobile app self-management intervention is delivered through a mobile application to patients recruited from an orthopedics clinic, which represents an outpatient clinic setting.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention is a mobile app self-management program for osteoarthritis, delivered remotely to patients regardless of the initial recruitment location (hospital orthopedics clinic), making the setting an outpatient or community-based one.
|
OK |
| feasibility |
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — The study has a sample size of 66 randomized participants and aims to evaluate clinical efficacy using primary outcomes related to physical function, self-efficacy, and self-management behaviors.
|
fully powered RCT
fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — This is designed as a fully powered clinical effectiveness trial with 66 participants (N=33 per group) evaluating clinical outcomes (physical function, quality of life, self-efficacy) with proper sample size calculation for testing efficacy of the intervention.
|
fully powered RCT
feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: fully powered RCT — The trial has an enrollment count of 66, focuses on clinical outcomes, and does not explicitly mention pilot or feasibility.
|
OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a single-modality behavioral intervention delivered via a mobile app, where features like peer support, appraisal, goal setting, and self-monitoring are integrated modules of one digital self-management strategy rather than distinct component types.
|
no
no → yes → no
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The mobile app self-management program combines multiple distinct components including behavioral self-management, peer support, educational goal-setting, self-monitoring of exercise, and symptom management strategies that work together as an integrated intervention.
Thinking: no — This is a single behavioral self-management intervention delivered via mobile app with multiple modules, not a combination of different intervention types.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is a single-modality mobile app self-management program focusing on self-efficacy and does not combine distinct components from different categories (e.g., pharmacologic, psychological).
Thinking: no — The intervention is a single behavioral/educational mobile app self-management program, without additional distinct modalities like pharmacologic or surgical components.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | yes | yes | yes | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom |
no
no → no
shaky reasoning✗ No consensus
Initial: no
Requery: no — The outcome measures focus on quality of care, self-efficacy, self-management behaviors, quality of life (EQ-5D), physical performance, and health services use, but do not include specific validated symptom scales or direct symptom assessments.
|
no
no → yes → yes
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The study measures symptoms through the Arthritis Self-efficacy Scale which includes specific subscales for pain and other symptoms assessment using validated rating scales.
Thinking: yes — The primary outcome Arthritis Self-efficacy Scale (ASE) includes subscales specifically measuring pain and other symptoms.
|
yes
yes → yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The trial measures osteoarthritis symptoms including pain using the Arthritis Self-efficacy Scale (ASE), which includes ASE: Pain and ASE: Other Symptoms subscales.
Thinking: no — All listed outcomes assess quality of care, self-efficacy, behaviors, function or quality of life, with no validated scale directly measuring symptom severity such as pain, nausea, fatigue, etc.
|
|
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | yes | yes | yes | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |