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

February 28, 2023 updated by: Poriya Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Poriyya, Israel, 15208
        • Recruiting
        • Baruch Padeh (Poriya) Medical Center
        • Contact:
        • Principal Investigator:
          • Liza Grosman-Rimon, MD
        • Sub-Investigator:
          • Daniel Minnes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loneliness levels
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poriya Medical Center

Investigators

  • Study Director: Erez Kachel, MD, Poriya Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2023

Primary Completion (Anticipated)

March 10, 2023

Study Completion (Anticipated)

May 10, 2023

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0079-19-POR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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