Health and access to healthcare in homeless people: Protocol for a mixed-methods study

ISRCTN	ISRCTN13187634
DOI	https://doi.org/10.1186/ISRCTN13187634
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	PI2020/0576
Sponsor	University of the Balearic Islands
Funders	The College of Nurses of the Balearic Islands, Govern Illes Balears

Submission date: 03/01/2022
Registration date: 06/01/2022
Last edited: 13/02/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Homelessness is a more complex problem than the simple lack of a place to live. Homeless people (HP) often suffer from poor health and premature death due to their limited access to healthcare and are also deprived of basic human and social rights. The study protocol described here aims to evaluate the complex relationship between homelessness and health, and identify the barriers and facilitators that impact access to healthcare by HP.

Who can participate?
The study aims to recruit about 300 adult homeless people in Palma.

What does the study involve?
The first phase of the study will involve HP completing specific health questionnaires to obtain information on health status, challenges during the COVID-19 pandemic, self-reported use of healthcare, diagnoses, pharmacologic treatments, substance abuse, diet quality, depression, human basic needs, and social support. The second phase of the study will involve interviews with HP to determine the effects of different personal, family, and structural factors on their life and health status.

What are the possible benefits and risks of participating?
There are no anticipated risks of participating. The results of this study will help to develop global health strategies that improve the health and access to healthcare in HP.

Where is the study run from?
The University of the Balearic Islands (Spain) in collaboration with Primary Care and General Direction of Public Health of the Balearic Islands (Spain)

When is the study starting and how long is it expected to run for?
From January 2020 to December 2022

Who is funding the study?
The College of Nurses of Balearic Islands (Spain) and the Government of the Balearic Islands (Spain)

Who is the main contact?
1. Dr. Aina M. Yañez, aina.yanez@uib.es
2. Mr Miguel Ángel Bedmar, mabedmar23@gmail.com

Contact information

Dr Miquel Bennasar-Veny
Scientific

Beatriu de Pinos Building
Balearic Islands University
Cra. de Valldemossa Km 7,5
Palma
07122
Spain

ORCID ID	0000-0003-1668-2141
Phone	+34971172367
Email	miquel.bennasar@uib.es

Dr Aina M. Yañez
Scientific

Beatriu de Pinos Building
Balearic Islands University
Cra. de Valldemossa Km 7,5
Palma
07122
Spain

ORCID ID	0000-0001-8527-3937
Phone	+34971172914
Email	aina.yanez@uib.es

Mr Miguel Angel Bedmar
Public

Cra. de Valldemossa Km 7,5
Palma
07122
Spain

Phone	+34971172914
Email	mabedmar23@gmail.com

Study information

Primary study design	Observational
Study design	Observational cross-sectional mixed-methods study using an explanatory sequential design
Secondary study design	Cross sectional study
Study type	Participant information sheet
Scientific title	Evaluating the health situation of homeless people in Spain and identifying the barriers and facilitators that impact access to healthcare
Study acronym	SENSELLAR
Study objectives	To evaluate the complex relationship between homelessness and health, and identify the barriers and facilitators that impact access to healthcare by homeless people.
Ethics approval(s)	Approved 08/10/2020, the Ethics Committee of Clinical Research of the Balearic Islands (CEI-IB) (Calle del calçat, 2A, 2ª planta, Polígono de Son Valentí, 07011 Palma (Illes Balears); +34-971177 378; ceic_ib@caib.es), ref: IB4301/20PI
Health condition(s) or problem(s) studied	Access to healthcare and health of homeless people
Intervention	The first phase will consist of a cross-sectional study of 300 homeless people. Specific health questionnaires will be used to obtain information on health status, challenges during the COVID-19 pandemic, self-reported use of healthcare, diagnoses, and pharmacologic treatments, substance abuse (DAST-10), diet quality (IASE), depression (PHQ-9), and human basic needs and social support (SSQ-6). The second phase will be a qualitative study of homeless people using the “life story” technique with purposive sampling. The interviews will be structured and defined using Nussbaum's capability approach and will be used to determine the effects of different personal, family, and structural factors on the life and health status of participants
Intervention type	Other
Primary outcome measure(s)	1. Health status measured using an ad hoc questionnaire at a single timepoint 2. Challenges faced during the COVID-19 pandemic measured using an ad hoc questionnaire at a single timepoint 3. Self-reported use of healthcare, diagnoses, and pharmacologic treatments measured using an ad hoc questionnaire at a single timepoint 4. Substance abuse measured using the Drug Abuse Screening Test (DAST-10) at a single timepoint 5. Diet quality measured using the Healthy Feeding Index (IASE) at a single timepoint 6. Depression measured using the Patient Health Questionnaire (PHQ-9) at a single timepoint 7. Human basic needs and social support measured using the Social Support Questionnaire (SSQ-6) at a single timepoint
Key secondary outcome measure(s)	Effects of different personal, family, and structural factors on the life and health status of participants measured using a qualitative interview at a single timepoint
Completion date	31/12/2022

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Aged ≥18 years 2. Living in Palma and meeting the European Typology of Homelessness and Housing Exclusion (ETHOS) classification 3. Agree to participate in the study and sign the informed consent document
Key exclusion criteria	1. Staying overnight in a private or municipal shelter for >3 months during the previous year 2. Having an acute episode of mental disease or being under the influence of alcohol or any drug during recruitment
Date of first enrolment	12/11/2020
Date of final enrolment	30/05/2022

Locations

Countries of recruitment

Spain

Study participating centre

Universitat de les Illes Balears

Cra. de Valldemossa Km 7,5
Palma
07122
Spain

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	The selection of the datasets generated during and/or analysed during the current study will be anonymised and stored in a publically available repository (http://zenodo.org).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		18/02/2022	13/02/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol (preprint)		15/09/2021	06/01/2022	No	No

Editorial Notes

13/02/2024: Publication reference added.
07/11/2022: The intention to publish date was changed from 01/11/2022 to 01/06/2023.
04/03/2022: Internal review.
24/01/2022: The public title was changed from 'Health and access to healthcare in homeless people' to 'Health and access to healthcare in homeless people: Protocol for a mixed-methods study'.
07/01/2022: Internal review.
06/01/2022: Trial’s existence confirmed by the Ethics Committee of Clinical Research of the Balearic Islands (CEI-IB).