PACE 10 year follow-up: feasibility study
Research type
Research Study
Full title
PACE trial 10 year follow-up: feasibility study
IRAS ID
214164
Contact name
Peter D White
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
54285094, ISRCTN; MREC/02/7/89, MREC West Midlands
Duration of Study in the UK
0 years, 2 months, 11 days
Research summary
This study will test the feasibility of undertaking a 10-year postal questionnaire follow-up of participants who took part in the PACE trial. This trial tested treatments for chronic fatigue syndrome and the main results were published in the Lancet. We wish to find out: how healthy participants are now, whether they have had any other illnesses since leaving the trial, how they are functioning, their economic status, how they view the concept of recovery, and whether they would be willing to participate in a qualitative study about their illness and current health. For this feasibility study we will use a random sample of 60 participants from two of the original five PACE trial centres. We will use original information provided for address details, as well as trace participants using their NHS numbers, and send questionnaires in the post. The questionnaires will include the original primary outcomes, a global health measure and measures of overall functioning. We will ask information about any new illnesses suffered since leaving the trial. Finally we will ask participants’ how they feel about having their data shared anonymously with other researchers and the general public. A return rate of 75% (45/60) returned questionnaires will deem a full 10-year follow-up study feasible.
REC name
London - South East Research Ethics Committee
REC reference
16/LO/2167
Date of REC Opinion
3 Jan 2017
REC opinion
Favourable Opinion