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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05764902
Enrollment
60
Registered
2023-03-13
Start date
2023-01-28
Completion date
2023-05-10
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loneliness

Keywords

Intensive Care Units, Older Adult, Aged

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.

Interventions

BEHAVIORALPatient-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.

Sponsors

Poriya Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.

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.

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Loneliness levelsReduction 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.

Countries

Israel

Contacts

Primary ContactDaniel J Minnes
MinnnesDan@gmail.com8606904989

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026