Condition category
Nervous System Diseases
Date applied
15/02/2017
Date assigned
02/03/2017
Last edited
02/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Alopecia (hair-loss) in adult survivors of critical illness has received limited attention in critical care research. Hair-loss is of minimal concern to the intensive care team, when patient survival is the primary objective of care given. However, hair-loss can prove distressing for the patient, especially after recovering from a serious illness. In a recent pilot study in Morriston Hospital (UK), it was found that 17% of patients attending the Intensive Care Unit (ICU) follow up clinic, complained of hair-loss. There is very little research about how often hair-loss occurs in survivors of a critical illness. The first objective of the study is to investigate the incidence and nature of hair-loss in adult survivors of critical illness. The second objective is to investigate the risk factors for hair-loss in adult survivors of critical illness.

Who can participate?
Adults over the age of 18 who are in the ICU for five days or more.

What does the study involve?
During participant's ICU stay, data is collected regarding their demographics and about their health variables that are considered a potential risk for alopecia. Three months after participants are discharged, they are sent a survey regarding potential hair loss to complete and return to the research team. If the survey is not returned after one month, participants receive a phone call by the researchers in order to assist them with their survey.

What are the possible benefits and risks of participating?
Participants may benefit from having potential risk factors for hair loss identified. There are no notable risks with participating.

Where is the study run from?
This study is being run from Morriston Hospital (UK) takes place in hospitals in Wales (UK).

When is the study starting and how long is it expected to run for?
August 2016 to December 2017

Who is funding the study?
Abertawe Bro Morgannwg University Health Board (UK)

Who is the main contact?
Dr Ceri Battle
Ceri.Battle@wales.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Ceri Battle

ORCID ID

http://orcid.org/0000-0002-7503-1931

Contact details

Physiotherapy Department
Morriston Hospital
Morriston
Swansea
SA6 6NL
United Kingdom
+44 179 270 3124
ceri.battle@wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 5

Study information

Scientific title

Alopecia in Survivors of CRitical Illness: a Mixed methods study

Acronym

ASCRIM

Study hypothesis

The aim of the study is to investigate the prevalence, nature and risk factors for alopecia in survivors of critical illness.

Ethics approval

North of Scotland Research Ethics Service, 21/11/2016, ref: 16/NS/0133

Study design

Mixed methods prospective observational epidemiological study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Alopecia

Intervention

This study consist of two phases. In the first phase, patients are approached to participate in the study. This is done when the patient has been in the Intensive Therapy Unit (ITU) for five or more days and is able to provide written consent. During the patient’s ITU stay, data collection is completed by the researcher, which involves collecting details about demographics and variables that are considered potential risk factors for alopecia, taken from the patient’s medical records. The researcher records age, sex, admission diagnosis, sepsis, past medical history, blood products transfused during stay, relevant drugs that are known risk factors for alopecia, physiological data and discharge data such as length of stay, mechanical ventilation days, respiratory/cardiovascular/renal support during stay.

The second phase of the study occurs three months post ITU discharge. The patient is sent a survey regarding alopecia to complete. If the patient fails to return the survey after one month, they are followed up with a phone call by the research team to assist with survey completion as required.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Prevalence and nature of patient reported alopecia in survivors of critical illness is measured using a patient reported survey at three months post ITU discharge.

Secondary outcome measures

Risk factors for alopecia in survivors of critical illness are measured using a patient record survey at three months post ITU discharge.

Overall trial start date

01/08/2016

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or more (no upper limit)
2. Capacity to consent to participation
3. Capacity to complete survey
4. ICU stay of five or more days
5. Survived to three months post ICU discharge

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Aged less than 18 years
2. No capacity to consent to participation
3. No capacity to complete survey
4. ICU stay of less than five days
5. Does not survive to three months post ICU discharge
6. Patients requiring chemotherapy that will potentially cause alopecia
7. Patients who suffer with any pre-existing alopecia / baldness

Recruitment start date

01/05/2017

Recruitment end date

30/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Morriston Hospital
Heol Maes Eglwys
Swansea
SA6 6NL
United Kingdom

Trial participating centre

University Hospital Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom

Trial participating centre

Nevill Hall Hospital
Brecon Road
Abergavenny
NP7 7EG
United Kingdom

Trial participating centre

Royal Glamorgan Hospital
Ynysmaerdy
Llantrisant
CF72 8XR
United Kingdom

Trial participating centre

Princess of Wales Hospital
Coity Road
Bridgend
CF31 1RQ
United Kingdom

Trial participating centre

Prince Charles Hospital
Gurnos Road
Merthyr Tydfil
CF47 9DT
United Kingdom

Trial participating centre

Bronglais Hospital
Caradoc Road
Aberystwyth
SY23 1ER
United Kingdom

Trial participating centre

Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom

Trial participating centre

Glan Clwyd Hospital
Rhuddlan Road
Bodelwyddan
LL18 5UJ
United Kingdom

Trial participating centre

Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom

Trial participating centre

Glangwili General Hospital
Dolgwili Road
Carmarthen
SA31 3AF
United Kingdom

Trial participating centre

Withybush Hospital
Fishguard Road
Haverfordwest
SA61 2PZ
United Kingdom

Sponsor information

Organisation

Abertawe Bro Morgannwg University Health Board

Sponsor details

R&D Department
ILS2
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
+44 179 253 0888
abm.rd@wales.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Abertawe Bro Morgannwg University Health Board

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes