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    Summary
    EudraCT Number:2021-001279-18
    Sponsor's Protocol Code Number:NHSCHECK
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-03-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2021-001279-18
    A.3Full title of the trial
    Overall Study Name: NHS CHECK - Health & Experiences of staff working at NHS Trusts and Nightingale Hospitals.

    Embedded RCT Full Title: Effectiveness of a smartphone app-based intervention in improving stress, resilience, wellbeing and mental health outcomes in a high-risk healthcare worker population during Covid-19: a randomised controlled parallel group trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Embedded RCT Short Title: Smartphone app-based mental health and wellbeing intervention for healthcare workers during Covid-19.
    A.4.1Sponsor's protocol code numberNHSCHECK
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKing’s College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKoa Health
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing’s College London
    B.5.2Functional name of contact pointResearch and Development
    B.5.3 Address:
    B.5.3.1Street AddressJames Clerk Maxwell Building, 57 Waterloo Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 8WA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+4402071886206
    B.5.6E-mailThomas.foulkes@kcl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Foundations App - Koa Health
    D.2.1.1.2Name of the Marketing Authorisation holderKoa Health
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFoundations App
    D.3.2Product code N/A
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeSmartphone based application
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mental Health and Wellbeing of Healthcare Staff
    E.1.1.1Medical condition in easily understood language
    Mental Health and Wellbeing of Healthcare Staff
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether the use of Foundations mobile application impacts stress, wellbeing, anxiety, depression, functioning, resilience and sleep in a real-world, high-risk healthcare worker cohort.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be aged 18 and over.
    2. Be an NHS-affiliated member of staff, working at, or with, the participating eighteen NHS CHECK sites.
    3. Completed baseline survey with NHS CHECK Cohort study and have consented to be contacted for further research as part of study.
    4. Be able to give informed consent to take part in research.
    5. Be able to understand and communicate in English.
    6. Have access to the internet to complete the surveys.
    7. Have access to an email address to facilitate application registration and receive survey links.
    8. Own a smartphone with access to the Apple and Google Application Stores.

    The following 18 NHS Trusts have been selected to include a mixture of urban and rural settings:

    Avon and Wiltshire Mental Health Mental Health Partnership Trust
    Cambridge University Hospitals NHS Foundation Trust
    Cambridgeshire and Peterborough NHS Foundation Trust
    Cornwall Partnership NHS Foundation Trust
    Devon Partnership NHS Foundation Trust
    East Suffolk and North Essex NHS Foundation Trust
    Gloucestershire Hospitals NHS Foundation Trust
    Guys and St Thomas' NHS Foundation Trust
    King's College Hospital NHS Foundation Trust
    Lancashire and South Cumbria NHS Foundation Trust
    Norfolk and Norwich University Hospitals Foundation Trust
    Nottinghamshire Healthcare NHS Foundation Trust
    Royal Papworth Hospital NHS Foundation Trust
    Sheffield Health and Social Care NHS Foundation Trust
    South London and Maudsley NHS Foundation Trust
    Tees Esk and Wear Valleys NHS Foundation Trust
    University Hospitals of Derby and Burton NHS Foundation Trust
    University Hospitals of Leicester NHS Foundation Trust
    E.4Principal exclusion criteria
    1. Plans to start new interventions after randomisation during eight week trial period (e.g. apps, psychological therapies and pharmacological therapies).
    E.5 End points
    E.5.1Primary end point(s)
    1. The GHQ-12 is a 12-item scale which screens for general (non-psychotic) psychiatric morbidity, (Goldberg et al., 1992).
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 and 8 weeks (alongside baseline)
    E.5.2Secondary end point(s)
    2. The Brief Resilience Scale (BRS) to measure resilience is a 6-item participant self-report measure, which assesses an individual’s ability to bounce back or recover from stress. (Smith et al., 2008).
    3. The GAD-7 is a well validated and widely used 7-item measure of anxiety. A change of 4 or more on the GAD has been found to be clinically significant across anxiety disorders. (Spitzer et al., 2006).
    4. The PHQ-9 is the 9-item depression module from the full PHQ. There is strong evidence for the validity of the PHQ-9 as a brief measure of depression severity. (Kroenke et al., 2001).
    5. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 7-item measure to enable the monitoring of subjective well-being and psychological functioning compared to the general population (all items are worded positively and address aspects of positive mental health) (Tennant et al., 2007).
    6. The 5-item Work and Social Adjustment Scale (WSAS) (Mundt et al., 2002).
    7. The 6-item Stanford Presenteeism Scale (SPS-6) (Koopman et al., 2002).
    8. The Minimal Insomnia Symptom Scale (MISS) is a 3-item scale which provides a brief measure of sleeping difficulties (Broman et al., 2008).
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 and 8 weeks (alongside baseline)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Treatment as usual
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of the trial will be upon completion of the 8 week follow-up survey (or loss to follow-up) for the participants who have taken part (aim for 700).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 650
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-03-09. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Once participants have read the information sheet, participants much provide online written consent prior to completing the baseline survey/taking part.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 700
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the eight week trial period, both intervention and wait-list control participants will be given full app access. They will be contacted by NHS CHECK and sent App access/log-in details. There are free to use the application for free.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United Kingdom
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