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

NCT05764902 | Unknown

• 1 other identifier: 0079-19-POR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness

Keywords

Intensive Care Units; Older Adult; Aged

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Control

NO INTERVENTION

Patients will receive standard of care.

Intervention

EXPERIMENTAL

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

Interventions

Patient-tailored intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poriya Medical Center: lead

Study Sites (1)

Baruch Padeh (Poriya) Medical Center

Poria – Neve Oved, 15208, Israel

RECRUITING

Related Publications (24)

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Study Officials

• Erez Kachel, MD

  Poriya Medical Center

  STUDY DIRECTOR

Central Study Contacts

Daniel J Minnes

CONTACT

8606904989; MinnnesDan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors who analyze the data will be blinded to the allocation of patients to the intervention or control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 13, 2023
• Study Start: January 28, 2023
• Primary Completion: March 10, 2023
• Study Completion: May 10, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-02

Locations

IL (1)