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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel J Minnes | Contact | 8606904989 | MinnnesDan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Erez Kachel, MD | Poriya Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baruch Padeh (Poriya) Medical Center | Recruiting | Poria – Neve Oved | 15208 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22710744 | Background | Perissinotto CM, Stijacic Cenzer I, Covinsky KE. Loneliness in older persons: a predictor of functional decline and death. Arch Intern Med. 2012 Jul 23;172(14):1078-83. doi: 10.1001/archinternmed.2012.1993. | |
| 25910392 | Background | Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352. |
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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.
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The assessors who analyze the data will be blinded to the allocation of patients to the intervention or control group.
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