Prevalence and risk factors of hair-loss in survivors of critical illness
| ISRCTN | ISRCTN59206964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59206964 |
| Secondary identifying numbers | Version 5 |
- Submission date
- 15/02/2017
- Registration date
- 02/03/2017
- Last edited
- 16/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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
Contact information
Public
Physiotherapy Department
Morriston Hospital
Morriston
Swansea
SA6 6NL
United Kingdom
 ORCID ID |
0000-0002-7503-1931 |
|---|---|
| Phone | +44 179 270 3124 |
| ceri.battle@wales.nhs.uk |
Study information
| Study design | Mixed methods prospective observational epidemiological study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Alopecia in Survivors of CRitical Illness: a Mixed methods study |
| 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(s) | North of Scotland Research Ethics Service, 21/11/2016, ref: 16/NS/0133 |
| 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 |
| Primary outcome measure | 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 study start date | 01/08/2016 |
| Overall study end date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| 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 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
- Wales
Study participating centres
Swansea
SA6 6NL
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Newport
NP20 2UB
United Kingdom
Abergavenny
NP7 7EG
United Kingdom
Llantrisant
CF72 8XR
United Kingdom
Bridgend
CF31 1RQ
United Kingdom
Merthyr Tydfil
CF47 9DT
United Kingdom
Aberystwyth
SY23 1ER
United Kingdom
Wrexham
LL13 7TD
United Kingdom
Bodelwyddan
LL18 5UJ
United Kingdom
LL57 2PW
United Kingdom
Carmarthen
SA31 3AF
United Kingdom
Haverfordwest
SA61 2PZ
United Kingdom
Sponsor information
Hospital/treatment centre
R&D Department
ILS2
Swansea University
Singleton Park
Swansea
SA2 8PP
Wales
United Kingdom
| Phone | +44 179 253 0888 |
|---|---|
| abm.rd@wales.nhs.uk | |
"ROR" |
https://ror.org/04zet5t12 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2019 | Yes | No | |
| Protocol file | version 5.2 | 18/10/2017 | 16/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
16/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
10/12/2018: Publication reference added.
