FiTPAD v1.0
Research type
Research Study
Full title
A prospective cohort study to determine the utility of a wearable fitness tracking device in the assessment of adults receiving, or planned to receive, immunoglobulin therapy, using a comparison group of adults not receiving immunoglobulin therapy.
IRAS ID
225527
Contact name
Stephen Jolles
Contact email
Sponsor organisation
Cardiff and Vale University Local Health Board
Clinicaltrials.gov Identifier
225527, Integrated Research Application System (IRAS)
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This study is designed to investigate the relationship between the timing of immunoglobulin therapy and activity levels. Discovering such a relationship may demonstrate the effect of immunoglobulin therapy and allow treatment regimes to be tailored to individual patients' needs.
We plan to study a range of disease areas where immunoglobulin therapy is used, including immunology, haematology, and neurology. We plan to use a readily available fitness tracking device (fitbit charge 2) with a range of outputs to measure activity.
Patients receiving, or who are planned to receive, immunoglobulin therapy, would be eligible to participate, along with a small comparison group of people not receiving immunoglobulin therapy.
Participants will be recruited from outpatient clinics in the various disciplines involved. Data collection will primarily be done through the post and online monitoring.
Participants will be asked to wear the fitness tracker for thirteen months, and complete daily diaries recording immunoglobulin use, respiratory tract infection symptoms, and wellbeing scores.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0212
Date of REC Opinion
7 Jul 2017
REC opinion
Favourable Opinion