Impact of the COVID-19 Pandemic on the Health Status of People Aged 75 and Over and Their Caregivers

Aging Clinical Trial

— CUIDAMOS+75  

Official title:

Multicentre Study on the Impact of the SARS-CoV-2 Pandemic on the Health Status of People Aged 75 and Over and Their Caregivers (CUIDAMOS+75 Project)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05249868
• Other study ID #: 20210009
• Secondary ID: PI21_00190PI21_0
• Status: Active, not recruiting
• Start date: June 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The measures to control the transmissibility of the Covid-19 pandemic have changed the daily routines of the population, increasing sedentary lifestyles, decreasing outdoor physical activity and limiting contact with neighbors, family and friends. This could be having negative consequences for the health of vulnerable people. The investigators want to know how this situation has affected the health of people aged 75 years or older and their caregivers and how the circumstances experienced may mark new care needs. To this end, will be analyzed clinical data, follow up people who have become ill with COVID-19 and those who have not, and interview groups of caregivers and patients to hear about the personal impact of the pandemic on them. This will allow us to explore what changes are needed in health care to achieve an improvement in the health and quality of life of this population. CUIDAMOS+75 seeks the commitment of the population and of the different people in charge of the health services from the very beginning.

Description:

Objective: To explore the impact of the pandemic SARS-CoV-2 on the state of health of people aged ≥75 years. Design: Mixed-methods study. 1) Multipurpose, ambispective, longitudinal population-based cohort study with real world data and 6 years of follow-up; 2) Prospective observational cohort study with 18 months of follow-up; 3) Qualitative study with a critical-social approach. Scope: Primary care in 11 Autonomous Regions. Population: People aged ≥75 years, attending healthcare centres in the study area. Sample: The population cohort will include the total population that meets the criteria, out of the estimated 1619620. The prospective cohort size is 1035, recruited on a probabilistic basis by clinical nurses. In the social critical approach the selection will be intentional and will progress towards theoretical sampling according to the emerging findings. V. outcome: Population-based cohort: nursing diagnostic and interventions and use of services; mortality, quality of life (EQ-5D) and functional capacity (Barthel) for cohort follow-up. V. exposure: SARS-CoV-2 infection. Sources: Clinical history, clinical interview, semi-structured interviews and focus groups. Analysis: Population cohort: to explore the evolution of diagnostic and interventions, a time series analysis will be carried out. Cohort study: Kaplan-Meier survival curves for mortality, functional change and quality of life. Cox proportional hazards models will be used to study the impact of infection on the three variables at 6, 12 and 18 months, adjusted for socio-demographic and clinical variables. Qualitative study: thematic, semiotic and discursive positions analysis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1035
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Have at least one entry in the electronic medical record during 2018 (Sub-study 1).
• Have at least one entry in the clinical history during the last 6 months of 2019 (Sub-study 2).
• Give informed consent (Sub-study 2 & 3).
• Family caregivers of dependent persons included in the population cohort (Sub-study 3).

Exclusion Criteria:

• Not belonging to National Health System centres in the territorial demarcations participating in the study (Sub-study 1).
• Not belonging to the quotas of the 105 participating nurses (Sub-study 2 & 3).
• Carers who have been caring for less than 6 months at the start of the pandemic, with sensory or cognitive deficits (Sub-study 3).

Related Conditions & MeSH terms

• Aging
• Caregiver Burden
• Caregivers
• COVID-19
• Frailty
• SARS-CoV-2 Infection

Intervention

Other:
• Exposure SARS-CoV-2 Infection
The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Positive confirmatory test on nucleic acid amplification (rRT-PCR) or having had symptoms for <5 days is positive on a PRAg test.

Locations

Country	Name	City	State
Spain	Milagros Rico-Blazquez	Madrid
Spain	Milagros Rico-Blázquez	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Fundación para la Investigación e Innovación Biosanitaria de la Comunidad de Madrid, Hospital del Mar Research Institute (IMIM), Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (17)

Alfano V, Ercolano S. The Efficacy of Lockdown Against COVID-19: A Cross-Country Panel Analysis. Appl Health Econ Health Policy. 2020 Aug;18(4):509-517. doi: 10.1007/s40258-020-00596-3. — View Citation

Borges-Machado F, Barros D, Ribeiro O, Carvalho J. The Effects of COVID-19 Home Confinement in Dementia Care: Physical and Cognitive Decline, Severe Neuropsychiatric Symptoms and Increased Caregiving Burden. Am J Alzheimers Dis Other Demen. 2020 Jan-Dec;3 — View Citation

Brown EE, Kumar S, Rajji TK, Pollock BG, Mulsant BH. Anticipating and Mitigating the Impact of the COVID-19 Pandemic on Alzheimer's Disease and Related Dementias. Am J Geriatr Psychiatry. 2020 Jul;28(7):712-721. doi: 10.1016/j.jagp.2020.04.010. Epub 2020 — View Citation

Cohen G, Russo MJ, Campos JA, Allegri RF. Living with dementia: increased level of caregiver stress in times of COVID-19. Int Psychogeriatr. 2020 Nov;32(11):1377-1381. doi: 10.1017/S1041610220001593. Epub 2020 Jul 30. — View Citation

Company-Sancho MC, Estupinan-Ramirez M, Sanchez-Janariz H, Tristancho-Ajamil R. The connection between nursing diagnosis and the use of healthcare resources. Enferm Clin. 2017 Jul-Aug;27(4):214-221. doi: 10.1016/j.enfcli.2017.04.002. Epub 2017 May 10. Eng — View Citation

Dubey S, Biswas P, Ghosh R, Chatterjee S, Dubey MJ, Chatterjee S, Lahiri D, Lavie CJ. Psychosocial impact of COVID-19. Diabetes Metab Syndr. 2020 Sep-Oct;14(5):779-788. doi: 10.1016/j.dsx.2020.05.035. Epub 2020 May 27. — View Citation

Freijomil-Vazquez C, Gastaldo D, Coronado C, Movilla-Fernandez MJ. When risk becomes illness: The personal and social consequences of cervical intraepithelial neoplasia medical surveillance. PLoS One. 2019 Dec 16;14(12):e0226261. doi: 10.1371/journal.pone — View Citation

Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352. — View Citation

Johnson VR, Jacobson KL, Gazmararian JA, Blake SC. Does social support help limited-literacy patients with medication adherence? A mixed methods study of patients in the Pharmacy Intervention for Limited Literacy (PILL) study. Patient Educ Couns. 2010 Apr — View Citation

Lam K, Lu AD, Shi Y, Covinsky KE. Assessing Telemedicine Unreadiness Among Older Adults in the United States During the COVID-19 Pandemic. JAMA Intern Med. 2020 Oct 1;180(10):1389-1391. doi: 10.1001/jamainternmed.2020.2671. — View Citation

Lamont RA, Nelis SM, Quinn C, Clare L. Social Support and Attitudes to Aging in Later Life. Int J Aging Hum Dev. 2017 Jan;84(2):109-125. doi: 10.1177/0091415016668351. Epub 2016 Sep 20. — View Citation

Mann DM, Chen J, Chunara R, Testa PA, Nov O. COVID-19 transforms health care through telemedicine: Evidence from the field. J Am Med Inform Assoc. 2020 Jul 1;27(7):1132-1135. doi: 10.1093/jamia/ocaa072. — View Citation

Mowbray H. In Beijing, coronavirus 2019-nCoV has created a siege mentality. BMJ. 2020 Feb 7;368:m516. doi: 10.1136/bmj.m516. No abstract available. — View Citation

Perez-Rodrigo C, Gianzo Citores M, Hervas Barbara G, Ruiz-Litago F, Casis Saenz L, Arija V, Lopez-Sobaler AM, Martinez de Victoria E, Ortega RM, Partearroyo T, Quiles-Izquierdo J, Ribas-Barba L, Rodriguez-Martin A, Salvador Castell G, Tur JA, Varela-Moreiras G, Serra-Majem L, Aranceta-Bartrina J. Patterns of Change in Dietary Habits and Physical Activity during Lockdown in Spain Due to the COVID-19 Pandemic. Nutrients. 2021 Jan 21;13(2):300. doi: 10.3390/nu13020300. — View Citation

Roschel H, Artioli GG, Gualano B. Risk of Increased Physical Inactivity During COVID-19 Outbreak in Older People: A Call for Actions. J Am Geriatr Soc. 2020 Jun;68(6):1126-1128. doi: 10.1111/jgs.16550. Epub 2020 May 14. No abstract available. — View Citation

Saltzman LY, Hansel TC, Bordnick PS. Loneliness, isolation, and social support factors in post-COVID-19 mental health. Psychol Trauma. 2020 Aug;12(S1):S55-S57. doi: 10.1037/tra0000703. Epub 2020 Jun 18. — View Citation

Saltzman LY, Pat-Horenczyk R, Lombe M, Weltman A, Ziv Y, McNamara T, Takeuchi D, Brom D. Post-combat adaptation: improving social support and reaching constructive growth. Anxiety Stress Coping. 2018 Jul;31(4):418-430. doi: 10.1080/10615806.2018.1454740. Epub 2018 Apr 12. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes caused by the SARS-CoV-2 pandemic in the use of health services in a population-based cohort of non-institutionalised people aged 75 years and older.	By analysing real-life data from electronic clinical records.	up to 1 year
Secondary	Changes from baseline prevalence of care needs of non-institutionalised people aged 75 and over in the context of the SARS-CoV-2 pandemic.	Sub-study 1: Longitudinal study of a population-based, multipurpose, ambispective cohort. Variables on nursing interventions will be collected through the primary care electronic medical record.	at the basal time.
Secondary	Changes from baseline prevalence of care needs of non-institutionalised people aged 75 and over in the context of the SARS-CoV-2 pandemic.	Sub-study 1: Longitudinal study of a population-based, multipurpose, ambispective cohort. Variables on nursing interventions will be collected through the primary care electronic medical record.	6 years follow-up.
Secondary	Number of participants with changes caused by the SARS-CoV-2 pandemic in the functional capacity of non-institutionalised people aged 75 and over.	Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on change in functioning will be collected using the Barthel scale.	18 months follow-up
Secondary	Number of participants with changes caused by the SARS-CoV-2 pandemic in the quality of life of non-institutionalised people aged 75 and over.	Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on change quality of life will be collected using the EQ-5D.	18 months follow-up
Secondary	Number of participants with changes caused by the SARS-CoV-2 pandemic in the cognitive capacity of non-institutionalised people aged 75 years and over.	Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on change cognitive capacity will be collected using the Mini Mental Status Examination.	18 months follow-up
Secondary	Number of participants with changes caused by the SARS-CoV-2 pandemic in the mental health of non-institutionalised people aged 75 and over.	Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on mental health capacity will be collected using the Hamilton Scale.	18 months follow-up
Secondary	Incidence of mortality caused by the SARS-CoV-2 pandemic among non-institutionalised persons aged 75 years and over.	Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Mortality data shall be studied through medical records.	18 months follow-up
Secondary	Understand and interpret the social, political and economic dimensions linked to the use of health services by people aged 75 and over and family caregivers during the pandemic and think about possible coping strategies.	Sub-study 3:Qualitative study with a social critical approach through semi-structured interviews for =75 years and focus groups for caregivers. A thematic analysis will be carried out, which will be complemented at the textual level by a semiotic analysis of discursive positions. In accordance with the critical character, discourse will be analysed as a reflection of ideological positions of inequality and domination.	zero time, baseline.