Clinical Trials Logo

Clinical Trial Summary

Objectives: To examine changes in health-related quality of life (HRQL), pain and function among patients with knee or hip osteoarthritis (OA) participating in digitally delivered exercise and education treatment for up to 12 or 24 month. Design: An observational longitudinal and repeated cross-sectional cohort study. We will include patients who had participated in the digitally delivered exercise and education treatment program Joint Academy® for 3, 6 , 9 , 12 and if enough patients also for 24 month. We will analyze both cross-sectional samples at each time point and a longitudinal sample that have participated for at least 12 month, with at least one follow-up in between. Outcomes: We will analyze HRQL with EQ-5D-5L, pain with Numeric Rating Scale (NRS) 0-10 (best to worst) and function with 30-sec chair stand test (CST) at baseline and at 3, 6, 9,12 and if possible 24 months during the treatment. Main outcome will be change in level in EQ-5D-5L dimensions. We will also analyze minimally clinical important changes (improved or not) and mean changes in EQ-5D-5L index score, pain and 30-sec chair stand test (CST). Logistic regression models and linear mixed models will be used for analysis. Analyses will be performed for repeated cross-sectional samples and a longitudinal sample.


Clinical Trial Description

International treatment guidelines recommend exercise, education and weight control (if needed) as first-line treatment for knee and hip osteoarthritis (OA). Still, evidence suggest that less than 50% of OA patients have participated in first-line treatment before getting joint replacement. Several observational and randomised controlled trials (RCTs) show that exercise therapy is effective in reducing pain, improving physical function and health-related quality of life (HRQL) at clinically important levels in the short-term. Quality of life is rated lower by people with OA compared to norm populations and measures of well-being are increasingly used as outcomes in health interventions. Face-to-face first-line OA treatment following the Better Care for persons with OsteoArthritis (BOA) or Good Life with osteoArthritis in Denmark (GLA:D) initiatives seem to have small but clinically significant effects on HRQL immediate after intervention, at six month and with maintained improvements at one year for knee but not hip OA. The digitally delivered first-line OA treatment program Joint Academy® (JA) was developed in Sweden in 2016 in an attempt to improve implementation and adherence to guidelines. The program is based on evidence from BOA. Initial observational studies show that both patients with hip and knee OA had clinically important improvements in pain and function at six weeks with sustained improvements up to 48 weeks of treatment. Further, HRQL dimensions mobility and pain/discomfort significantly improved after six weeks, while others did not (self-care, usual activities, and anxiety/depression. However, the long-term change in HRQL during digitally delivered first-line OA treatment is not known. Therefore, we aim to identify changes in HRQL, pain and function, during up to12 months of digitally delivered first-line treatment. A second aim was to examine if changes differs between hip/knee and women/men. Outcomes Outcomes were collected at start and at standardized time points during the treatment. They were chosen based on the International Consortium for Health Outcomes Measurement Standard Set for Hip & Knee Osteoarthritis (ICHOM), self-entered using the digital program interface and stored in the JA database. HRQL was evaluated every third month using the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L), which is a generic quality of life measurement tool. The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The levels of severity range from no problems (1) to extreme problems/unable to (5) and are recorded for each of the five dimensions. The raw scores are also converted to a single EQ-5D index value using a scoring algorithm (British tariff was used) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state). A change of ≥0.03 in the index was considered as minimally clinical important change (MCIC) according to a comprehensive review of musculoskeletal disorders. Joint pain was assessed using the Numerical Rating Scale (NRS), with the instruction Mark on this scale how much pain you had the last week in your hip/knee, followed by a 0-10 scale where 0 indicates No pain and 10 indicates Maximum pain. A difference of 15 of 100 for absolute improvement (slightly or moderately) is considered as MCIC. Physical function was assessed with the 30-s chair-stand test (CST) performed by the participant with the help of an instruction video with a coupled visual timer. The patient entered the performed number of repetitions after each test. The 30-s CST is recommended by the Osteoarthritis Research Society International (OARSI) as a performance-based functional test for knee and hip OA (Dobson 2013). A difference of two rises is considered as MCIC. Data on the participants' overall health and characteristics such as OA location (hip/knee), age, sex, educational level (), height, weight and medical conditions (xx) were collected at inclusion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05026580
Study type Observational
Source Joint Academy
Contact Helena Hörder, Med dr
Phone +46406550292
Email [email protected]
Status Recruiting
Phase
Start date September 2021
Completion date June 2022

See also
  Status Clinical Trial Phase
Recruiting NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Recruiting NCT04034004 - Chronic Low Back Pain and Meditation Early Phase 1
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT01077414 - Phenomenological Study of Psycho-Socio-Spiritual Healing in the Context of Chronic or Life-Threatening Illness
Recruiting NCT04262232 - Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population N/A
Recruiting NCT04061733 - New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis N/A
Not yet recruiting NCT05022810 - A Bioequivalence Study of a New Paracetamol Oral Suspension 24mg/ml Compared to the Marketed Paracetamol Oral Suspension (Panadol Baby and Infant 24mg/ml) in Healthy Adult Subjects Phase 1
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Completed NCT01198197 - PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Early Phase 1
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Not yet recruiting NCT04710992 - Influence of Percutaneous Electrolysis on Endogenous Pain Modulation N/A