the Role of Technology in Elderly Patients

NCT05000099 | Completed

• 1 other identifier: 2020-01125
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Starting from December 2019, the Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-COV-2) disease spread rapidly from China into the world, with about two Mio cases confirmed around the world. In Switzerland, more than 26'000 cases have been confirmed so far, and health authorities declared in March the needs for social isolation and have banned visits to hospitalized patients and to nursing home residents. Loneliness and isolation is a significant concern for the elderly patients as well as for their families that may significantly affect physical and mental health in both. SILVER aims to evaluate the role of programmed video calls with families:

• on mood, anxiety, fear of death and pain perception in patients hospitalized or in nursing homes during the SARS-COV-2 pandemic.
• in relieving the familiar caregiver anxiety and fear of death of others
• in relieving the professional caregiver anxiety. SILVER is an international study involving both acute, rehabilitation geriatric units and nursing homes; we will enroll all the patients present in the participating centers. Patients will be allowed to chose between video and phone calls, the following dimensions will be evaluated:
• Delirium risk: using the Confusion Assessment Method (CAM)
• Mood: using the 5-item Geriatric Depression Scale (GDS)
• Anxiety: using the Clinical Anxiety Scale (GAS).
• Fear of death (self and others): using the Collett-Lester scale. In parallel, health professionals and family caregivers will be evaluated for anxiety at baseline and every week after intervention set-up by the Clinical Anxiety Scale (CAS). Family caregivers will also be evaluated with the fear of death scale (sub-scale fear of death of others). Finally, to evaluate the appreciation for video call communication in patients and caregivers we will use a Likert scale.

Conditions

Anxiety; Depression; Aging; Social Isolation

Outcome Measures

Primary Outcomes (4)

• 4-point likert scale (LKRT)

  appreciation of video calls by patients and families rage 0-4, 4 represent the better outcome

  0-7 days

• Geriatric anxiety scale (GAS-10)

  measure of anxiety, The GAS-10 form, contains a total of 10 items, the answers are yes or no and the possible scores range from 0 to 10, with a cut-off point for anxiety at 6. The higher the score, the greater the anxiety.

  0-7 days

• Collett Lester Fear of Death scale (CL-FOD) for self and others

  fear of death scale of patients, The CL-FODS contains 28 items, with seven items on each of the four subscales: Fear of Death of Self, Dying of Self, Death of Others, and Dying of Others. It is answered on a 5-point Likert format anchored as follows: 1 (not) and 5 (very). The total score in each subscale could range from 7 to 35, with higher scores denoting higher anxiety from death or dying.

  0-7 days

• geriatric depression scale (GDS-5)

  mood evaluation for patients. the GDS-5 contains 5 items, the total score range from 0 to 5, the clinical cut-off for suspicion of depression is 2

  0-7 days

Secondary Outcomes (1)

• Collett Lester Fear of Death scale (CL-FOD) for others

  0-7 days

Study Arms (2)

phone calls

patients choosing phone calls as preferred communication technique

Other: video calls

video call

patients choosing video calls as preferred communication technique

Other: video calls

Interventions

video calls OTHER

A tablet for video-calls will be available for patients and families. Two video-calls of maximum 15' will be organized every week; in addition, patients will be allowed to do video-call upon request. Video-calls will be performed using Skype or WhatsApp video or Face-time

Also known as: phone calls

phone calls; video call

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SILVER is an observational multicentre study. Patients hospitalized in two geriatric Unit in Switzerland (the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne and the Hôpitaux Universitaire Genève (HUG) in Geneva,) and in one geriatric unit in Italy (Santa Misericordia Hospital in Perugia) and their families

You may qualify if:

• patients of 65 years and older hospitalized in the participating unit during the absence of visits due to the SARS-CoV2 pandemic.
• Patients and families willing to participate.

You may not qualify if:

• patients or families who refuse to participate.
• Clinical Dementia Rating (CDR) equal or higher than two.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Patrizia D'amelio

Lausanne, 1012, Switzerland

Location

Related Publications (1)

• Durst AV, Graf CE, Ruggiero C, Zekry D, Boccardi V, Monney L, Joss I, Vuilloud K, Vespignani G, Bosshard W, Mecocci P, Bula CJ, D'Amelio P. Fighting social isolation in times of pandemic COVID-19: the role of video calls for older hospitalized patients. Aging Clin Exp Res. 2022 Sep;34(9):2245-2253. doi: 10.1007/s40520-022-02188-8. Epub 2022 Jul 6.

  PMID: 35794314 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Social Isolation

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Social Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: December 2, 2020
• Primary Completion: March 4, 2021
• Study Completion: July 31, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)