Cognitive Outcomes During COVID-19 confiNemeNt in Elderly and Their Caregivers Using Technologies for DEMentia

NCT04385797 | Unknown

• 1 other identifier: CONNECT DEM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 has forced worldwide the implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine and home confinement. This restriction of daily life activities and separation from loved ones may lead to social isolation and loneliness with health-related consequences in community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, an inadequate access to healthcare and social support services may aggravate chronic conditions. Technology home-based interventions emerge for combating social isolation and loneliness preventing the risk of viral exposure. The aim of this multicentre cohort study is to explore, analyze and determine the impact of social isolation on: 1) cognition, quality of life, mood, technophilia and perceived stress of community-dwelling older adults with mild cognitive impairment or mild dementia, and on caregiver burden; 2) health and social care services access and utilization, and 3) cognitive, social and entertainment use of ICTs. This study will be conducted in two Spanish regions Andalucía (Málaga) and Cataluña (Tarrasa). In total 200 dyads, consisting of a person with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregiver will be contacted by telephone. Potential respondents will be participants of the SMART 4 MD (N=100) and TV-AssistDem (N=100) clinical trials. The change in means in the variables will be analyzed comparing baseline results in the previous studies with those during and after confinement using the ANOVA test of repeated measures or the non-parametric Friedman test if appropriate. The performance of a multivariate analysis of variance (ANCOVA) to introduce possible covariates will also be contemplated. A 95% confidence level will be used.

Conditions

Mild Cognitive Impairment; Dementia

Keywords

COVID-19; Social Isolation; Informal caregivers; Cognition; Facilities and Services Utilization; Technologies; ICTs; Telehealth

Outcome Measures

Primary Outcomes (1)

• Change on cognitive function in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

  The Mini-Mental State Examination (MMSE) (23) will be used to assess the cognitive function of the PMCI/MD. The most common cutoff scores for cognitive impairment and dementia are ranging 23 to 27 over 30. As telephone call interviewing will be the safest means to communicate with the PMCI/MD during and after the COVID-19 pandemic the 22 items telephone version of the MMSE will be used (24). All points of the MMSE can be covered in the telephone version except the last section assessing language and motor skills. In the phone version, we will ask the subject to repeat a phrase and name one item (For example: "Tell me, what is the name of the object you are using to talk to me?"). However, a second item will be not be named, nor will be the person be asked to follow a three-stage command, read and obey a sentence, write a sentence, or copy an intersecting pentagon as in the original version.

  Through study completion, an average of 6 months

Secondary Outcomes (8)

• Change on quality of life in Alzheimer´s Disease in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

  Through study completion, an average of 6 months

• Change on quality of life in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

  Through study completion, an average of 6 months

• Change on mood in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

  Through study completion, an average of 6 months

• Change on technophilia in people with mild cognitive impairment or mild dementia prior to, during and after confinement.

  Through study completion, an average of 6 months

• Change on perceived stress in people with mild cognitive impairment or mild dementia during and after confinement.

  Through study completion, an average of 6 months

Study Arms (1)

Dyads

Community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers

Other: Telephone interview

Interventions

Telephone interview OTHER

Sociodemographic data. Clinical data. PMCI/MD quality of life, cognition, depression, technophilia and perceived stress and caregiver quality of life and burden assessments.

Dyads

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling older adults with mild cognitive impairment or mild dementia

You may qualify if:

• Having participated in the SMART 4 MD, TV-AssistDem and INFINITy clinical trials

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Instituto de Investigacion Biomedica de Malaga-IBIMA

Málaga, 29009, Spain

Location

Related Publications (13)

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  PMID: 32112977 BACKGROUND

• Legido-Quigley H, Mateos-Garcia JT, Campos VR, Gea-Sanchez M, Muntaner C, McKee M. The resilience of the Spanish health system against the COVID-19 pandemic. Lancet Public Health. 2020 May;5(5):e251-e252. doi: 10.1016/S2468-2667(20)30060-8. Epub 2020 Mar 18. No abstract available.

  PMID: 32199083 BACKGROUND

• Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.

  PMID: 32112714 BACKGROUND

• World Health Organization. Mental Health and Psychosocial Considerations During COVID-19 Outbreak. World Heal Organ 2020;(January):1-6.

  BACKGROUND

• Gomez-Gallego M, Gomez-Amor J, Gomez-Garcia J. [Validation of the Spanish version of the QoL-AD Scale in alzheimer disease patients, their carers, and health professionals]. Neurologia. 2012 Jan;27(1):4-10. doi: 10.1016/j.nrl.2011.03.006. Epub 2011 May 12. Spanish.

  PMID: 21570161 BACKGROUND

• Garcia-Gordillo MA, Adsuar JC, Olivares PR. Normative values of EQ-5D-5L: in a Spanish representative population sample from Spanish Health Survey, 2011. Qual Life Res. 2016 May;25(5):1313-21. doi: 10.1007/s11136-015-1164-7. Epub 2015 Oct 19.

  PMID: 26482825 BACKGROUND

• Anderberg P, Eivazzadeh S, Berglund JS. A Novel Instrument for Measuring Older People's Attitudes Toward Technology (TechPH): Development and Validation. J Med Internet Res. 2019 May 23;21(5):e13951. doi: 10.2196/13951.

  PMID: 31124467 BACKGROUND

• Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.

  PMID: 16673626 BACKGROUND

• Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.

  PMID: 11574710 BACKGROUND

• Fernandez-San Martin M, Andrade-Rosa C, Molina JD, Munoz PE, Carretero B, Rodriguez M, Silva A. Validation of the Spanish version of the geriatric depression scale (GDS) in primary care. Int J Geriatr Psychiatry. 2002 Mar;17(3):279-87. doi: 10.1002/gps.588.

  PMID: 11921157 BACKGROUND

• Tsoi KKF, Chan JYC, Hirai HW, Wong A, Mok VCT, Lam LCW, Kwok TCY, Wong SYS. Recall Tests Are Effective to Detect Mild Cognitive Impairment: A Systematic Review and Meta-analysis of 108 Diagnostic Studies. J Am Med Dir Assoc. 2017 Sep 1;18(9):807.e17-807.e29. doi: 10.1016/j.jamda.2017.05.016. Epub 2017 Jul 25.

  PMID: 28754516 BACKGROUND

• Dura-Perez E, Goodman-Casanova JM, Vega-Nunez A, Guerrero-Pertinez G, Varela-Moreno E, Garolera M, Quintana M, Cuesta-Vargas AI, Barnestein-Fonseca P, Gomez Sanchez-Lafuente C, Mayoral-Cleries F, Guzman-Parra J. The Impact of COVID-19 Confinement on Cognition and Mental Health and Technology Use Among Socially Vulnerable Older People: Retrospective Cohort Study. J Med Internet Res. 2022 Feb 22;24(2):e30598. doi: 10.2196/30598.

  PMID: 35049505 DERIVED

• Goodman-Casanova JM, Dura-Perez E, Guerrero-Pertinez G, Barnestein-Fonseca P, Guzman-Parra J, Vega-Nunez A, Varela-Moreno E, Cuesta-Vargas A, Mayoral-Cleries F. Cognitive Outcomes During COVID-19 Confinement Among Older People and Their Caregivers Using Technologies for Dementia: Protocol for an Observational Cohort Study. JMIR Res Protoc. 2021 May 18;10(5):e26431. doi: 10.2196/26431.

  PMID: 33909588 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; COVID-19; Social Isolation

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Fermín Mayoral-Cleries

  Instituto de Investigación Biomédica de Malaga (IBIMA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 13, 2020
• Study Start: May 4, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-04

Locations

ES (1)