The health and coping strategies of nursing home residents and their relatives during the COVID-19 pandemic

ISRCTN	ISRCTN12345167
DOI	https://doi.org/10.1186/ISRCTN12345167
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	SPA-COVID19
Sponsor	University of Applied Sciences and Arts Western Switzerland
Funder	Haute école Spécialisée de Suisse Occidentale (ref: 09-O20)

Submission date: 13/10/2021
Registration date: 14/10/2021
Last edited: 13/12/2024

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The COVID-19 pandemic hit older adults particularly hard, especially those living in nursing homes and little scientific research has looked at the specific measures implemented to protect them. This study's primary aim is to assess the physical and mental health of nursing home residents and their relatives following the implementation of the exceptional confinement measures taken because of the COVID-19 epidemic. The secondary aim is to explore the lived experiences of the stressors perceived by older adults and their relatives, as well as the support strategies implemented by health professionals and their results.

Who can participate?
Nursing home residents over 65 years old, their relatives, and healthcare professionals working on the unit for more than 3 months

What does the study involve?
Participants are asked to complete several questionnaires, and the confinement measures implemented in older adults' nursing homes are identified. Data are collected from several sources (individual interviews, focus groups, field notes). Interviews are planned with about 12 representatives of each group of participants (residents and relatives). Two focus groups made up of healthcare professionals will explore their perceptions of residents' and relatives' lived experiences of stressors, the coping strategies those two groups implemented to deal with them and what those strategies' results were.

What are the possible benefits and risks of participating?
There is no benefit to participating in the study. The study procedure does not pose a major health risk to the residents and their relatives.

Where is the study run from?
University of Applied Sciences and Arts Western Switzerland

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

Who is funding the study?
University of Applied Sciences and Arts Western Switzerland

Who is the main contact?
Prof. Claudia Ortoleva Bucher
c.ortolevabucher@ecolelasource.ch

Contact information

Prof Claudia Ortoleva Bucher
Scientific

La Source School of Nursing Sciences
HES-SO University of Applied Sciences and Arts Western Switzerland
Lausanne
1004
Switzerland

ORCID ID	0000-0002-8411-4181
Phone	+41 (0)21 556 40 42
Email	c.ortolevabucher@ecolelasource.ch

Study information

Primary study design	Observational
Study design	Concurrent mixed-methods (QUANTITATIVE/qualitative) observational study
Secondary study design	Mixed methods (QUANT/qual)
Study type	Participant information sheet
Scientific title	The health and coping strategies of nursing home residents and their relatives during the COVID-19 pandemic: a mixed-methods study protocol
Study acronym	SPA-COVID19
Study objectives	1. Describe the level of symptoms (post-traumatic stress, anxiety, depression, social maladjustment and somatic disorders), post-traumatic growth and quality of life of nursing home residents and their relatives after the COVID-19 pandemic. 2. Describe the strategies implemented (by residents and relatives) for coping with the COVID-19 pandemic. 3. Explore residents and relatives lived experiences of their perceived stressors during the COVID-19 pandemic and their links to any potential physical or mental health symptoms, post-traumatic growth and quality of life. 4. Explore which stressors healthcare and support professionals observed affecting residents and their relatives. 5. Explore which strategies healthcare and support professionals implemented to support residents and their relatives and help them cope with the stressors they faced during the COVID-19 pandemic, including their results.
Ethics approval(s)	Approved 14/12/2020, Human Research Ethics Committee of the Canton of Vaud (Avenue de Chailly 23, Lausanne, 1012, Switzerland; +41 (0)21 316 18 30; scientifique.cer@vd.ch), ref: 2020-02397
Ethics approval additional information	Approved 14/12/2020, Human Research Ethics Committee of the Canton of Vaud (Avenue de Chailly 23, 1012 Lausanne, Switzerland; +41 (0)21 316 18 30; scientifique.cer@vd.ch), ref: 2020-02397
Health condition(s) or problem(s) studied	Physical and mental health of residents of nursing homes residents and their relatives during the COVID-19 pandemic
Intervention	This study is based on a concurrent mixed design (QUAN/Qual). Quantitative data will be collected through questionnaires and qualitative data will be collected through semi-structured interviews for residents and their relatives and through focused focus groups for health professionals. Quantitative phase: Participants are asked to complete several relevant, validated questionnaires, and the confinement measures implemented in older adults' nursing homes are identified. The study population includes all the nursing home residents in four French-speaking cantons of Switzerland (and their relatives) who are living through the COVID-19 pandemic. Descriptive statistics will be calculated for the scores of the GHQ-12, IES-6, PSS, Brief Cope, PTGI-SP, WHOQOL-BREF and WHOQOL-OLD scales. Correlational analyses will be considered. Qualitative phase: Data are collected from several sources (individual semi-structured interviews, focus groups, field notes). Interviews are planned with about 12 representatives of each group of participants (residents and relatives) or until data saturation. Two focus groups made up of healthcare professionals will be constituted to explore their perceptions of residents' and relatives' lived experiences of stressors, the coping strategies those two groups implemented to deal with them and what those strategies' results were. The interviews and focus groups will be subjected to a thematic contents analysis. Integrating the quantitative and qualitative data will take place jointly with data interpretation.
Intervention type	Other
Primary outcome measure(s)	There is a single timepoint for both quantitative and qualitative data collection (from April 2021 to February 2022) Level of symptom intensity reported by residents and relatives using the General Health Questionnaire (GHQ-12, Likert scoring)
Key secondary outcome measure(s)	There is a single timepoint for both quantitative and qualitative data collection (from April 2021 to February 2022): Quantitative: 1. Levels of psychophysiological activation intensity, reviviscence, and avoidance reported by the residents and the relatives using the Impact of Event Scale-6 (IES-6, Likert scoring) 2. Frequency of use of the 14 types of coping strategies by APs and relatives measured using the Brief-Cope questionnaire (Likert scoring) 3. Level of perceived stress reported by APs and relatives measured using the Perceived Stress Scale (PSS, Likert scoring) 4. Level of intensity of post-traumatic growth reported by residents and relatives measured using the short form of the Posttraumatic Growth Inventory (PTGI-SF, Likert scoring) 5. Level of quality of life reported by relatives using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF, Likert scoring) 6. Level of quality of life reported by residents using the World Health Organization Quality of Life instrument - Older Adults (WHOQOL-OLD, Likert scoring) Qualitative: 1. Stressors perceived by residents and relatives collected from interviews using thematic analysis 2. Stressors of residents and their relatives as perceived by health care professionals collected from focus groups using thematic analysis 3. An understanding of the phenomenon under study, i.e., the process of adaptation to stressors resulting from the COVID-19 pandemic by residents and their relatives, will be formulated by integration of the qualitative and quantitative results (mixed methods analyses)
Completion date	31/12/2022

Eligibility

Participant type(s)	Mixed
Age group	Mixed
Sex	All
Target sample size at registration	372
Key inclusion criteria	Nursing home residents: 1. Over 65 years old 2. Able to discern and speak and understand French Relatives: 1. Able to discern and speak and understand French Healthcare professionals: 1. Working on the unit for more than 3 months 2. Have a caring relationship with the residents and the family member
Key exclusion criteria	Residents: 1. The presence of major irreversible neurocognitive disorders Relatives: 1. There are no exclusion criteria Healthcare professionals: 1. Temporary worker or a student
Date of first enrolment	01/04/2021
Date of final enrolment	28/02/2022

Locations

Countries of recruitment

Switzerland

Study participating centre

University of Applied Sciences and Arts Western Switzerland

La Source School of Nursing Sciences
Avenue Vinet 30
Lausanne
1004
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	All the data collected is coded and kept securely at La Source School of Nursing. When dealing with quantitative data, each participant will be attributed an anonymous administrative code. Data will be stored on an SRP directory on La Source School of Nursing's server, which is housed in a data centre in Switzerland. All interviews are audio-recorded in full. When this qualitative data is transcribed verbatim onto a Word 365 ProPlus® file, each participant is assigned an anonymous administrative code instead of their name. Residents' codes begin with the letters 'RES' and the letter 'Q' for qualitative data, followed by a two-digit number, starting with RESQ01 for the first resident interviewed and so on in chronological order. The same system is followed with relatives (e.g. RELQ04) and healthcare professionals (e.g. PROQ12). All the participants are free to withdraw from the study at any moment without incurring any penalties or consequences with regard to the future care or services they might rightfully expect. Should a participant decide to withdraw, for whatever reason or at whatever moment, any data that have already been coded will not be destroyed but rather will still be analysed as specified in the research information sheet. Results will be presented in an aggregated form so that no participants will be identifiable in lectures or publications. Only the principal investigator (Prof. Claudia Ortoleva Bucher) will have access to the key linking participants' codes to their names and identities, and this will only be used if absolutely necessary. All members of the research team will only have access to coded data. The file containing the key to participants anonymity will be protected by a password known only to the principal investigator.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		09/10/2024	13/12/2024	Yes	No
Protocol article		24/03/2022	20/06/2024	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/12/2024: Publication reference added.
20/06/2024: The following changes were made:
1. The intention to publish date was changed from 30/06/2024 to 30/12/2024.
2. Publication reference added.
13/12/2023: The intention to publish date was changed from 31/12/2023 to 30/06/2024.
16/11/2021: The recruitment end date has been changed from 31/12/2021 to 28/02/2022 and the primary outcome measure and secondary outcome measures have been updated accordingly.
14/10/2021: Trial's existence confirmed by the Human Research Ethics Committee of the Canton of Vaud.