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

ISRCTN ISRCTN13187634
DOI https://doi.org/10.1186/ISRCTN13187634
Secondary identifying numbers PI2020/0576
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 logoORCID 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 logoORCID 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

Study designObservational cross-sectional mixed-methods study using an explanatory sequential design
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Community
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluating the health situation of homeless people in Spain and identifying the barriers and facilitators that impact access to healthcare
Study acronymSENSELLAR
Study objectivesTo 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) studiedAccess to healthcare and health of homeless people
InterventionThe 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 typeOther
Primary outcome measure1. 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
Secondary outcome measuresEffects of different personal, family, and structural factors on the life and health status of participants measured using a qualitative interview at a single timepoint
Overall study start date01/01/2020
Completion date31/12/2022

Eligibility

Participant type(s)Other
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants300
Key inclusion criteria1. 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 criteria1. 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 enrolment12/11/2020
Date of final enrolment30/05/2022

Locations

Countries of recruitment

  • Spain

Study participating centre

Universitat de les Illes Balears
Cra. de Valldemossa Km 7,5
Palma
07122
Spain

Sponsor information

University of the Balearic Islands
University/education

Cra. de Valldemossa Km 7.5
Palma
07122
Spain

Phone +34-971173000
Email osrgestiotecnica@uib.es
Website https://www.uib.eu
ROR logo "ROR" https://ror.org/03e10x626

Funders

Funder type

Government

The College of Nurses of the Balearic Islands

No information available

Govern Illes Balears

No information available

Results and Publications

Intention to publish date01/06/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planThe research protocol of the study will be send to publish in a high-impact peer review journal. Planned publication of results in a high-impact peer-review journal.
IPD sharing planThe 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 (preprint) 15/09/2021 06/01/2022 No No
Protocol article 18/02/2022 13/02/2024 Yes 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).