Clinical trial NCT05811858: Investigating Medical Research Trends in Osteoarthritis Clinical Trials
Official title: Analyzing Factors Impacting Patient Involvement in Osteoarthritis Clinical Research
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoarthritis
Keywords: osteoarthritis
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with osteoarthritis who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.

Brief summary: Clinical research participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future osteoarthritis patients during clinical study.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Participant has a diagnosis of osteoarthritis.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
* Pregnant or lactating woman
* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

Primary outcomes:
measure: Rate of patients who decide to enroll in an osteoarthritis clinical study.
timeFrame: 3 months
measure: Number of osteoarthritis patients who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Stabile M, Van Ryssen B, Minei S, Coppieters E, Crovace A, Lacitignola L, Staffieri F. Observational study of the clinical value of the canine osteoarthritis staging tool. Vet J. 2022 May-Jun;283-284:105832. doi: 10.1016/j.tvjl.2022.105832. Epub 2022 Apr 27.
citation: Akesson KS, Sunden A, Stigmar K, Fagerstrom C, Pawlikowska T, Ekvall Hansson E. Enablement and empowerment among patients participating in a supported osteoarthritis self-management programme - a prospective observational study. BMC Musculoskelet Disord. 2022 Jun 8;23(1):555. doi: 10.1186/s12891-022-05457-9.
citation: Ellis KR, Cuthbertson CC, Carthron D, Rimmler S, Gottfredson NC, Bahorski SG, Phillips A, Corbie-Smith G, Callahan L, Rini C. A Longitudinal Observational Study of Multimorbidity and Partner Support for Physical Activity Among People with Osteoarthritis. Int J Behav Med. 2021 Dec;28(6):746-758. doi: 10.1007/s12529-021-09985-x. Epub 2021 Apr 2.