Quality of Life Clinical Trial
Official title:
Effectiveness of Routine Measurement of Health-Related Quality of Life in Improving the Outcomes of Patients With Musculoskeletal Problems - A Randomized Controlled Trial
Verified date | May 2022 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim and Objectives: This is an effectiveness-implementation hybrid trial that aims to find out whether the implementation of routine measurement and reporting on the patient's EQ-5D-5L HRQOL data with an electronic platform can improve HRQOL and pain in patients with chronic knee or back problems in primary care. The investigators will also assess the acceptability of routine electronic measurement and reporting of the EQ-5D-5L in real-world primary care. Method: This is a multi-center prospective cluster-randomized controlled trial in six public primary care clinics in Hong Kong. The six clinics will be randomized to the intervention or control group. We shall recruit 1374 (229 from each clinic) subjects with symptomatic chronic knee or back problems through the attending doctors in the clinics. Subjects of the Intervention clinics will complete the electronic EQ-5D-5L at recruitment and every follow up during the next 12 months, and a report on their longitudinal EQ-5D-5L data will be shown to the doctors during the consultations. Subjects of the control clinics will receive care as usual. All subjects will complete a set of patient reported outcome measures (PRO) including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) on HRQOL and a 10-point Pain Rating Scale (PRS), and a structured questionnaire on sociodemographics, morbidity and service utilization rates at recruitment, and at 3, 6 and 12 months by telephone. Outcome Measures and Data Analysis: The primary outcome is change in WOMAC total score. The secondary outcomes are change in pain, other PRO scores and doctor rated severity of disease. Group difference in changes of WOMAC and other outcome scores over time will be analyzed using generalized estimating equation model under intention-to-treat principle. The acceptability of routine measurement of HRQOL by electronic EQ-5D-5L will be analyzed by descriptive statistics. Potential application: Routine measurement of HRQOL by an electronic EQ-5D-5L platform can be applied to other outpatient clinics to improve care of MS problems and other conditions to facilitate more effective and patient-centered care.
Status | Completed |
Enrollment | 1374 |
Est. completion date | April 30, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. adults aged 18 years or above 2. b) has doctor-diagnosed symptomatic knee and/or back pain problem that is expected to last for one month or more 3. scheduled for at least one follow-up visits in the clinic within 12 months 4. has given written consent to participate in this study Exclusion Criteria: 1. life expectancy less than 12 months (judged by the doctor), 2. has cancer 3. too ill (both physically or cognitively) to complete a questionnaire 4. unable to communicate in Chinese 5. does not give consent to participate in the study |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference in the health service utilization rates between intervention group and control group | Health service utilization included monthly frequency of outpatient consultations with western/Chinese medicine practitioners, allied health service visits, accident and emergency (A&E) department attendance, and admissions to hospitals. | At baseline, and 3 months, 6 months and 12 months after baseline | |
Other | Difference in the drug and other treatment utilization rates between intervention group and control group | Medication use in the past one month will be asked in the survey to evaluate the drug treatment utilization rates. | At baseline, and 3 months, 6 months and 12 months after baseline | |
Other | Difference in the patient acceptability of routine measurement of HRQOL by the electronic EQ-5D-5L between intervention group and control group | The acceptability of routine completion of the electronic EQ-5D-5L will be evaluated by the perceived ease of use and perceived usefulness scales based on the Technology Acceptability Model (TAM), which was translated and validated on the local Chinese population. | At baseline, and 3 months, 6 months and 12 months after baseline | |
Primary | The change in HRQOL measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) global score | The WOMAC is a widely used condition specific HRQOL measure to assess pain, stiffness and physical function of patients with MS problems. It has been applied to patients with hip and/or knee osteoarthritis, low back pain, rheumatoid arthritis and fibromyalgia. It consists of 24 items on 3 domains: pain (5 items), stiffness (2 items) and physical function (17 items). Each question is rated on a 5-point Likert scale from 0 to 4, with lower scores indicating lower levels of symptoms or impairment. The item scores in each domain subscale are summated to a domain score. The global WOMAC score is calculated by summating the three domain scores. A Chinese version of WOMAC is available and has been shown to be valid, reliable and sensitive in Chinese patients. | At baseline, and 3 months, 6 months and 12 months after baseline | |
Secondary | The change in pain score measured by the 10-point Pain Scale | The patient will be asked to rate their pain that best represents the intensity of their pain using a scale from 0 to 10, where 0 indicates no pain and 10 indicates the worse pain. | At baseline, and 3 months, 6 months and 12 months after baseline | |
Secondary | The change in patient-reported outcomes (PRO) - SF-6D utility score | The SF-6D is a preference-based measure of health, derived from the SF-36 Health Survey, that generates a utility score. It has 6 items measuring six HRQOL dimensions of physical function (PF), role limitation (RL), social functioning (SF), bodily pain (BP), mental health (MH) and vitality (VT). The SF-6D responses have a combination of 18,000 health states. Each health state can be converted to a composite preference (utility) score from 0 indicating death to 1 indicating perfect health. The Chinese SF-6D was validated in the Chinese population in Hong Kong, and the Hong Kong population-based scoring algorithm was established. The mean SF-6D utility score of the Hong Kong Chinese population is 0.78. | At baseline, and 3 months, 6 months and 12 months after baseline | |
Secondary | The change in patient-reported outcomes (PRO) - global health measured by the Global Rating Scale (GRS) | The GRS on change in health will be used to assess the patient's self-perception of any change in the overall health condition on a 7-point scale: (-3,(much worse), -2 (worse), -1 (a little worse), 0 (no change), 1 (a little better), 2 (better), and 3 (much better)). | At baseline, and 3 months, 6 months and 12 months after baseline | |
Secondary | The change in patient-reported outcomes (PRO) - patient enablement measured by the Patient Enablement Instrument (PEI) score | The PEI is a 6-item questionnaire that measures the patient's perceived change in coping with illness and self-care. Each item is rated on a 3-point (0, 1, and 2) scale. The sum of the item scores gives the final PEI score, with higher scores indicating better enablement. The Chinese version was shown to be a valid, reliable and sensitive outcome measure among Chinese patients in Hong Kong. | At baseline, and 3 months, 6 months and 12 months after baseline | |
Secondary | The change in clinician-reported disease severity | The diagnosis and duration of the chief musculoskeletal problem will be reported by the attending doctor. The attending doctor will rate patient's disease severity on a 5-point Likert scale: 1. no problem, 2. mild, 3. moderate, 4. severe and 5.very severe. | At baseline, and 3 months, 6 months and 12 months after baseline | |
Secondary | The change in clinician-reported disease progression | The diagnosis and duration of the chief musculoskeletal problem will be reported by the attending doctor. In each follow-up clinic consultation, the attending doctor will rate patient's disease progression on a 7-point scale (-3 much worse, -2 worse, -1 a little worse, 0 no change, 1 a little better, 2 better, and 3 much better). | At baseline, and 3 months, 6 months and 12 months after baseline |
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