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Clinical Trials/NCT05764902
NCT05764902
Recruiting
Not Applicable

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

Poriya Medical Center1 site in 1 country60 target enrollmentJanuary 28, 2023
ConditionsLoneliness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Loneliness
Sponsor
Poriya Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Loneliness levels
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 28, 2023
End Date
May 10, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Poriya Medical Center
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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