Interventions to Reduce Loneliness in Elderly Patients in the Cardiac ICU (CICU)

Loneliness Clinical Trial

Official title:

Interventions to Reduce Loneliness in Elderly Patients in the Cardiac ICU (CICU): A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764902
• Other study ID #: 0079-19-POR
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2023
• Est. completion date: May 10, 2023

Study information

• Verified date: February 2023
• Source: Poriya Medical Center
• Contact: Daniel J Minnes
• Phone: 8606904989
• Email: MinnnesDan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial aims to study whether patient-tailored interventions can reduce loneliness levels in elderly patients admitted to the Cardiac ICU (CICU). The study will involve an experimental group that will receive tailored interventions based on their needs and preferences, and a control group that will receive standard care. The primary goal of the trial is to determine if patient-tailored interventions can effectively reduce loneliness in patients staying in the CICU. The trial is interventional in nature and will compare results between the two groups.

Description:

This interventional clinical trial is designed to investigate the effects of patient-tailored interventions on reducing loneliness levels in elderly patients admitted to the Cardiac ICU (CICU). The aim of this study is to determine if tailored interventions can improve the well-being and quality of life of elderly patients who experience loneliness during their stay in the hospital.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• patients who were able to communicate effectively and cooperate with staff members

• 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 under the age of 70 years old

• 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

Related Conditions & MeSH terms

• Loneliness

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Israel	Baruch Padeh (Poriya) Medical Center	Poriyya

Sponsors (1)

Lead Sponsor	Collaborator
Poriya Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (24)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Loneliness levels	We developed a 12-item self-reported questionnaire by adapting questions from two established loneliness scales: the De Jong Gierveld Loneliness Scale and the UCLA Loneliness Scale. Two unique questions were also included in the survey. Each item was rated on a 5-point Likert scale. Total loneliness scores ranged from 12 to 60, with higher scores indicating greater loneliness.	Reduction in loneliness levels will be assessed at baseline and weekly during the patient's stay in the CICU until immediately before discharge, for a total of 4 weeks.