Interventions to Reduce Loneliness in Elderly Patients in the Cardiac ICU (CICU)
NCT ID: NCT05764902
Last Updated: 2023-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-01-28
2023-05-10
Brief Summary
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Detailed Description
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The primary research question is: Could patient-tailored interventions be used to reduce loneliness in patients staying in the CICU? The study will involve two groups of participants: an experimental group that will receive tailored interventions and a control group that will receive standard care.
Participants in the experimental group will receive tailored interventions by CICU staff based on their expressed needs and preferences. The interventions will be personalized to the individual patient and will be individualized based on survey responses from patients in the experimental group. The interventions will be implemented throughout the patient's stay in the CICU.
The control group will receive standard care, which includes medical treatment and monitoring, but will not receive any patient-tailored interventions aimed at reducing loneliness levels.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control
Patients will receive standard of care.
No interventions assigned to this group
Intervention
The intervention group will be given an additional questionnaire assessing individual needs and preferences. CICU staff will provide patient-tailored interventions based on the expressed needs and preferences of those in the intervention group.
Patient-tailored intervention
The intervention group will receive various tailored interventions designed to address multiple patient preferences, including sleeping, eating, and resting habits, hobbies, visitation preferences, religious and spiritual needs, preferences for independence and privacy, and any other specific requests or requirements.
Interventions
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Patient-tailored intervention
The intervention group will receive various tailored interventions designed to address multiple patient preferences, including sleeping, eating, and resting habits, hobbies, visitation preferences, religious and spiritual needs, preferences for independence and privacy, and any other specific requests or requirements.
Eligibility Criteria
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Inclusion Criteria
* patients who had stayed in the CICU for a minimum of 48 hours
* patients who met the age criteria of being over 70 years old
Exclusion Criteria
* patients who were unconscious or on ventilators
* patients who were admitted immediately after surgery
* patients with hemodynamic and/or respiratory instability
* patients with cognitive impairments, such as dementia and/or Alzheimer's disease
70 Years
ALL
Yes
Sponsors
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Poriya Medical Center
OTHER
Responsible Party
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Principal Investigators
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Erez Kachel, MD
Role: STUDY_DIRECTOR
Poriya Medical Center
Locations
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Baruch Padeh (Poriya) Medical Center
Poria – Neve Oved, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Perissinotto CM, Stijacic Cenzer I, Covinsky KE. Loneliness in older persons: a predictor of functional decline and death. Arch Intern Med. 2012 Jul 23;172(14):1078-83. doi: 10.1001/archinternmed.2012.1993.
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.
Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
Adepoju OE, Chae M, Woodard L, Smith KL, Herrera L, Han D, Howard DL, Dobbins J, Ory M. Correlates of Social Isolation Among Community-Dwelling Older Adults During the COVID-19 Pandemic. Front Public Health. 2021 Dec 10;9:702965. doi: 10.3389/fpubh.2021.702965. eCollection 2021.
Ernst M, Niederer D, Werner AM, Czaja SJ, Mikton C, Ong AD, Rosen T, Brahler E, Beutel ME. Loneliness before and during the COVID-19 pandemic: A systematic review with meta-analysis. Am Psychol. 2022 Jul-Aug;77(5):660-677. doi: 10.1037/amp0001005. Epub 2022 May 9.
National Academies of Sciences, Engineering, and Medicine; Division of Behavioral and Social Sciences and Education; Health and Medicine Division; Board on Behavioral, Cognitive, and Sensory Sciences; Board on Health Sciences Policy; Committee on the Health and Medical Dimensions of Social Isolation and Loneliness in Older Adults. Social Isolation and Loneliness in Older Adults: Opportunities for the Health Care System. Washington (DC): National Academies Press (US); 2020 Feb 27. Available from http://www.ncbi.nlm.nih.gov/books/NBK557974/
Hawkley LC, Cacioppo JT. Loneliness matters: a theoretical and empirical review of consequences and mechanisms. Ann Behav Med. 2010 Oct;40(2):218-27. doi: 10.1007/s12160-010-9210-8.
Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
Cacioppo JT, Hawkley LC, Thisted RA. Perceived social isolation makes me sad: 5-year cross-lagged analyses of loneliness and depressive symptomatology in the Chicago Health, Aging, and Social Relations Study. Psychol Aging. 2010 Jun;25(2):453-63. doi: 10.1037/a0017216.
Hawkley LC, Preacher KJ, Cacioppo JT. Loneliness impairs daytime functioning but not sleep duration. Health Psychol. 2010 Mar;29(2):124-9. doi: 10.1037/a0018646.
Hawkley LC, Thisted RA, Cacioppo JT. Loneliness predicts reduced physical activity: cross-sectional & longitudinal analyses. Health Psychol. 2009 May;28(3):354-63. doi: 10.1037/a0014400.
Wilson RS, Krueger KR, Arnold SE, Schneider JA, Kelly JF, Barnes LL, Tang Y, Bennett DA. Loneliness and risk of Alzheimer disease. Arch Gen Psychiatry. 2007 Feb;64(2):234-40. doi: 10.1001/archpsyc.64.2.234.
Cacioppo S, Grippo AJ, London S, Goossens L, Cacioppo JT. Loneliness: clinical import and interventions. Perspect Psychol Sci. 2015 Mar;10(2):238-49. doi: 10.1177/1745691615570616.
Masi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17.
Fakoya OA, McCorry NK, Donnelly M. Loneliness and social isolation interventions for older adults: a scoping review of reviews. BMC Public Health. 2020 Feb 14;20(1):129. doi: 10.1186/s12889-020-8251-6.
Boekhout JM, Volders E, Bolman CAW, de Groot RHM, Lechner L. Long-Term Effects on Loneliness of a Computer-Tailored Intervention for Older Adults With Chronic Diseases: A Randomized Controlled Trial. J Aging Health. 2021 Dec;33(10):865-876. doi: 10.1177/08982643211015027. Epub 2021 May 7.
Luo Y, Hawkley LC, Waite LJ, Cacioppo JT. Loneliness, health, and mortality in old age: a national longitudinal study. Soc Sci Med. 2012 Mar;74(6):907-14. doi: 10.1016/j.socscimed.2011.11.028. Epub 2012 Jan 25.
Valtorta N, Hanratty B. Loneliness, isolation and the health of older adults: do we need a new research agenda? J R Soc Med. 2012 Dec;105(12):518-22. doi: 10.1258/jrsm.2012.120128. No abstract available.
Czaja SJ, Boot WR, Charness N, Rogers WA, Sharit J. Improving Social Support for Older Adults Through Technology: Findings From the PRISM Randomized Controlled Trial. Gerontologist. 2018 May 8;58(3):467-477. doi: 10.1093/geront/gnw249.
Gardiner C, Geldenhuys G, Gott M. Interventions to reduce social isolation and loneliness among older people: an integrative review. Health Soc Care Community. 2018 Mar;26(2):147-157. doi: 10.1111/hsc.12367. Epub 2016 Jul 13.
Knox SS, Uvnas-Moberg K. Social isolation and cardiovascular disease: an atherosclerotic pathway? Psychoneuroendocrinology. 1998 Nov;23(8):877-90. doi: 10.1016/s0306-4530(98)00061-4.
Williams CYK, Townson AT, Kapur M, Ferreira AF, Nunn R, Galante J, Phillips V, Gentry S, Usher-Smith JA. Interventions to reduce social isolation and loneliness during COVID-19 physical distancing measures: A rapid systematic review. PLoS One. 2021 Feb 17;16(2):e0247139. doi: 10.1371/journal.pone.0247139. eCollection 2021.
Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
De Jong Gierveld J, Van Tilburg T. The De Jong Gierveld short scales for emotional and social loneliness: tested on data from 7 countries in the UN generations and gender surveys. Eur J Ageing. 2010 Jun;7(2):121-130. doi: 10.1007/s10433-010-0144-6. Epub 2010 Apr 9.
Other Identifiers
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0079-19-POR
Identifier Type: -
Identifier Source: org_study_id
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