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

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ClinicalTrials.gov Identifier: NCT04385797
Recruitment Status : Active, not recruiting
First Posted : May 13, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.


Condition or disease Intervention/treatment
Mild Cognitive Impairment Dementia Other: Telephone interview

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Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Cognitive Outcomes During COVID-19 confiNemeNt in Elderly and Their Caregivers Using Technologies for DEMentia
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Group/Cohort Intervention/treatment
Dyads
Community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers
Other: Telephone interview
Sociodemographic data. Clinical data. PMCI/MD quality of life, cognition, depression, technophilia and perceived stress and caregiver quality of life and burden assessments.




Primary Outcome Measures :
  1. Change on cognitive function in people with mild cognitive impairment or mild dementia prior to, during and after confinement. [ Time Frame: Through study completion, an average of 6 months ]
    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.


Secondary Outcome Measures :
  1. Change on quality of life in Alzheimer´s Disease in people with mild cognitive impairment or mild dementia prior to, during and after confinement. [ Time Frame: Through study completion, an average of 6 months ]

    The Quality of Life-Alzheimer's Disease Scale (QoL-AD) (19-22) is an instrument specifically designed to measure QoL in PMCI/MD from the perspective of both the patient and the informal caregiver. It is a 13-item measure, which includes assessments of the person´s relationships with friends and family, financial situation, physical condition, mood, memory, and an overall assessment of life quality. Response are 4-point multiple choice options (1 = poor, 2= fair, 3= good, 4 = excellent). Scale scores range from 13 to 52, with higher scores indicating greater quality of life.

    When cognitive function may be compromised, informal caregivers will complete the QoL-AD, on behalf of the PMCI/MD.


  2. Change on quality of life in people with mild cognitive impairment or mild dementia prior to, during and after confinement. [ Time Frame: Through study completion, an average of 6 months ]

    The European Quality of Life 5 Dimensions 3 Levels (EuroQoL-5D-3L) is a standardized generic instrument consisting of a descriptive system and a visual analogue scale (VAS).

    The descriptive system comprises 5 dimensions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, moderate problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits can be combined into a 5-digit number that describes the patient's health state.

    The VAS records the patient's self-rated health on a vertical scale, where the endpoints are 100 = 'The best health you can imagine' and 0 = 'The worst health you can imagine'.

    EuroQoL-5D-3L has been shown to correlate well with QoL-AD, indicating that using both measures side-by-side is compatible.


  3. Change on mood in people with mild cognitive impairment or mild dementia prior to, during and after confinement. [ Time Frame: Through study completion, an average of 6 months ]
    The Short Form of the Geriatric Depression Scale (GDS) (25) will be used to assess mood. Of the 15 items, 10 indicate depression when answered positively, while the rest (1, 5, 7, 11, 13) when answered negatively. Scores of 0-4 are considered normal, 5-8 indicate mild depression, 9-11 moderate depression, and 12-15 severe depression.

  4. Change on technophilia in people with mild cognitive impairment or mild dementia prior to, during and after confinement. [ Time Frame: Through study completion, an average of 6 months ]
    The Instrument for Measuring Older People's Attitudes Toward Technology (TechPH) measures older people's attitudes and enthusiasm for health technology (26). This instrument refers to technophilia as a person's enthusiasm for and positive feelings toward their technology use and absence of the fears and doubts some older people could have about their ability to manage using new technology. The six items of the instrument measure two factors of technophilia: 3 items concerning techEnthusiasm and 3 items techAnxiety. Response are constructed with a five-point Likert scale questionnaire, ranging from 1 (fully disagree) to 5 (fully agree).

  5. Change on perceived stress in people with mild cognitive impairment or mild dementia during and after confinement. [ Time Frame: Through study completion, an average of 6 months ]
    The Perceived Stress Scale (PSS) measures the degree to which situations in one's life are appraised as stressful. The scale has 10 questions regarding feelings and thoughts during the last month and are rated according to frecuency 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items

  6. Change on caregiver burden prior to, during and after confinement. [ Time Frame: Through study completion, an average of 6 months ]
    The Zarit Burden Interview (ZBI-12) is a 12-item scale with each answer chosen from a 5-point Likert scale (Nearly always=4, Quite frequently=3, Sometimes=2, Rarely=1, Never=0). It is a shortened version of the original scale, was developed specifically for informal caregivers of PMCI/MD and covers issues such as caregiver stress and the degree to which caring is affecting their health and social life. Total score range 0 to 48 (0-10= no to mild burden, 10-20= mild to moderate burden >20= high burden).

  7. Change on healthcare and social support services access prior to, during and after confinement. [ Time Frame: Through study completion, an average of 6 months ]
    The Client Service Receipt Inventory (CSRI) (32,33) scale will be used to evaluate the service utilization. This scale is an internationally used method for gathering data on service utilization and other domains relevant for economic analysis of mental health care. It has five sections: background client information, accommodation and living situation, employment history, earnings and benefits, a record of services usually used and information about informal caregiver support. The sections assessed will be consultations, admissions and visits, grouped into subsections according to hospital, specialist, primary or home care. Treatment related to hospital admissions or illness exacerbation will also be assessed. It´s adaptability ensures it is compatible with the research aims, context, participants' likely circumstances, and the quantity and precision of information required.

  8. Change from health, cognitive, social, informative and entertainment related uses of ICT during and after confinement. [ Time Frame: Through study completion, an average of 6 months ]
    Use of ICTs (SmartPhone, Tablet, Computer, Smart-TV, or other) to contact healthcare and social support services, to stimulate cognition, to facilitate social connectedness (telephone call, video call, texting...), to access COVID-19 information and to enable entertainment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community-dwelling older adults with mild cognitive impairment or mild dementia
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385797


Locations
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Spain
Instituto de Investigacion Biomedica de Malaga-IBIMA
Málaga, Spain, 29009
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Investigators
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Principal Investigator: Fermín Mayoral-Cleries Instituto de Investigación Biomédica de Malaga (IBIMA)
Publications:
World Health Organization. Mental Health and Psychosocial Considerations During COVID-19 Outbreak. World Heal Organ 2020;(January):1-6.

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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT04385797    
Other Study ID Numbers: CONNECT DEM
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
COVID-19
Social Isolation
Informal caregivers
Cognition
Facilities and Services Utilization
Technologies
ICTs
Telehealth
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders