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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

    p.d.white@qmul.ac.uk

  • 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 participantsā€™ 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