Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371696
Status:
COMPLETED
Last Update Posted:
2006-09-04
First Post:
2006-09-01
Brief Title:
Feasibility of n-of-1 Trials - a Pilot Study
Sponsor:
University of Bristol
Organization:
University of Bristol
Study Overview
Official Title:
Pilot Study of the Feasibility of n-of-1 Trials the Individualisation of Treatments for Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2003-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to provide essential pilot data on the feasibility of conducting n-of-1 trials within secondary care within the UK notably to test the process of recruitment and design aspects of such trials assess the acceptability of this research method to patients explore the experiences of patients involved determine the most appropriate treatment for individual patients
Detailed Description:
Whilst the large scale randomised controlled trial RCT remains the scientific gold standard for evaluating therapies in clinical medicine the assumption made that the treatment effect demonstrated is generalisable and applicable to all patients is unlikely to be true There will inevitably be some patients who benefit from a particular treatment more than others N-of-1 trials are a means of conducting RCTs in individual patients with the added opportunity to use patient generated outcome measures Patients act as their own control and receive all treatments under comparison more than once in a random sequence While n-of-1 trial methodology is reasonably well specified they remain under-exploited and little is known about the process aspects of conducting such trials or the experiences and views of those who participate in them The time commitment by patients and health professionals is not inconsiderable and there may well be particular problems with recruitment and drop out N-of-1 trials rely on co-operation between individual clinicians and patients however no work has been undertaken to explore the ways in which patient-practitioner relationships and their experiences and views influence the progress and outcome of n-of-1 trials
Patients with confirmed osteoarthritis OA of the knee selected for a mix of gender age weight will be recruited to the n-of-1 trials to compare either an NSAID diclofenac with simple analgesic paracetamol or a standard knee support with a heat retaining support Patients will undergo a 1 hour semi-structured interview before the trial commences and once the trial is completed or terminated Patients treated with supportsdrugs will receive each treatment for a period of onetwo weeks respectively for 3 cycles order determined at random Patients will complete daily diaries including standard patient questionnaires and a patient generated outcome measure Qualitative interviews and observational methods will be employed to study practitioner patient relationships decision to participate expectations and experience appropriateness and acceptability of research design and measures Patients declining to take part will be approached to explore reasons for not participating
Patients with confirmed osteoarthritis OA of the knee selected for a mix of gender age weight will be recruited to the n-of-1 trials to compare either an NSAID diclofenac with simple analgesic paracetamol or a standard knee support with a heat retaining support Patients will undergo a 1 hour semi-structured interview before the trial commences and once the trial is completed or terminated Patients treated with supportsdrugs will receive each treatment for a period of onetwo weeks respectively for 3 cycles order determined at random Patients will complete daily diaries including standard patient questionnaires and a patient generated outcome measure Qualitative interviews and observational methods will be employed to study practitioner patient relationships decision to participate expectations and experience appropriateness and acceptability of research design and measures Patients declining to take part will be approached to explore reasons for not participating
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None