Clinical trial NCT05764902: Interventions to Reduce Loneliness in Elderly Patients in the Cardiac ICU (CICU)
Official title: Interventions to Reduce Loneliness in Elderly Patients in the Cardiac ICU (CICU): A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Loneliness
Keywords: Intensive Care Units
Older Adult
Aged
Lead sponsor: Poriya Medical Center
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Loneliness levels
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Poriyya
country: Israel
facility: Baruch Padeh (Poriya) Medical Center
Study officials:
affiliation: Poriya Medical Center
name: Erez Kachel, MD
role: STUDY_DIRECTOR
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