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

Sponsor

Poriya Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05764902

Collaborator

(none)

Enrollment

Location

Arms

3.4

Anticipated Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Loneliness	Behavioral: Patient-tailored intervention	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This randomized controlled trial will evaluate the impact of tailored interventions on loneliness levels of patients admitted to the Cardiac ICU (CICU) at the Baruch Padeh Poriya Medical Center. A questionnaire using a 12-point Likert scale, adapted from the University of California Los Angeles (UCLA) and De Jong Gierveld Loneliness Scales, will be used to assess loneliness levels at CICU admission and discharge. Patients will be randomized into the intervention or control group. The intervention group will receive an additional questionnaire to assess their individual needs and preferences. CICU staff will provide individualized interventions to address the expressed needs and preferences of the intervention group, while the control group will receive standard care. Changes in loneliness levels during CICU hospitalization will be compared between the groups.This randomized controlled trial will evaluate the impact of tailored interventions on loneliness levels of patients admitted to the Cardiac ICU (CICU) at the Baruch Padeh Poriya Medical Center. A questionnaire using a 12-point Likert scale, adapted from the University of California Los Angeles (UCLA) and De Jong Gierveld Loneliness Scales, will be used to assess loneliness levels at CICU admission and discharge. Patients will be randomized into the intervention or control group. The intervention group will receive an additional questionnaire to assess their individual needs and preferences. CICU staff will provide individualized interventions to address the expressed needs and preferences of the intervention group, while the control group will receive standard care. Changes in loneliness levels during CICU hospitalization will be compared between the groups.

Masking:

Single (Outcomes Assessor)

Masking Description:

The assessors who analyze the data will be blinded to the allocation of patients to the intervention or control group.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 28, 2023

Anticipated Primary Completion Date :

Mar 10, 2023

Anticipated Study Completion Date :

May 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Patients will receive standard of care.
Experimental: 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.	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.

Arm

Intervention/Treatment

No Intervention: Control

Patients will receive standard of care.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Loneliness levels [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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baruch Padeh (Poriya) Medical Center	Poriyya		Israel	15208

Sponsors and Collaborators

Poriya Medical Center

Investigators

Study Director: Erez Kachel, MD, Poriya Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Poriya Medical Center

ClinicalTrials.gov Identifier:

NCT05764902

Other Study ID Numbers:

0079-19-POR

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Poriya Medical Center

Intensive Care Units

Older Adult

Aged

Study Results

No Results Posted as of Mar 13, 2023