Clinical trial NCT06390254: Resilience-Building Nursing Intervention for Elderly Well-being
Official title: Effectiveness of a Resilience-Building Nursing Intervention on Psychological Well-being in Community-Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological Well-being in Older Adults
Resilience Building Intervention
Community Dwelling Older Adults
Keywords: Resilience
Psychological well-being
Older adults
Nursing intervention
Community-dwelling
Geriatrics
Quality of life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional study model for this trial follows a randomized controlled design. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive the resilience-building nursing intervention, while the control group will receive standard care. This design allows for a rigorous evaluation of the effectiveness of the intervention by comparing outcomes between the two groups. Blinding of participants and investigators may or may not be feasible depending on the nature of the intervention. The study will adhere to established protocols for randomization, allocation concealment, and blinding to minimize bias and ensure the validity of the findings.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the impact of a resilience-enhancing nursing intervention on the psychological well-being of older adults living in the community. Participants will benefit from individualized nursing support designed to bolster their resilience and coping skills. This intervention will be customized to meet personal requirements and provided in a nurturing setting. Engaging in this study could result in enhanced well-being and life quality. Although some minor discomforts may arise during assessments or interventions, the confidentiality and rights of the participants will be rigorously safeguarded.

Detailed description: Background:

As the global population ages, there is an increasing need to address the psychological well-being of older adults living independently in the community. Previous research has highlighted the importance of resilience in maintaining mental health and coping with life stressors among older individuals. However, there is limited evidence on the effectiveness of specific interventions aimed at enhancing resilience in this population.

Objective:

The primary objective of this study is to evaluate the effectiveness of a resilience-building nursing intervention in improving the psychological well-being of community-dwelling older adults. Secondary objectives include assessing the impact of the intervention on factors such as social support, coping strategies, and quality of life.

Study Design:

This study will employ a randomized controlled trial design. Participants will be randomly assigned to either the intervention group, receiving the resilience-building nursing intervention, or the control group, receiving standard care.

Intervention:

The resilience-building nursing intervention will consist of individualized sessions delivered by trained nurses. The intervention will focus on enhancing participants\&#39; resilience through skill-building exercises, cognitive-behavioral techniques, and psychoeducation. Sessions will be tailored to address the unique needs and challenges of each participant.

Participants:

The target population for this study includes community-dwelling older adults aged 65 and above who are experiencing mild to moderate psychological distress. Participants will be recruited from community centers, senior living facilities, and primary care clinics.

Procedures:

Participants will undergo baseline assessments to collect demographic information and baseline measures of psychological well-being. Those assigned to the intervention group will receive the resilience-building nursing intervention over a specified period, with follow-up assessments conducted at regular intervals to evaluate outcomes.

Outcome Measures:

Primary outcome measures will include changes in psychological well-being, as assessed by standardized scales such as the Geriatric Depression Scale and the Psychological Well-being Scale. Secondary outcome measures will include social support, coping strategies, and quality of life.

Statistical Analysis:

Data will be analyzed using appropriate statistical methods, including t-tests, chi-square tests, and linear regression. Sample size calculations will ensure adequate power to detect meaningful differences between groups.

Ethical Considerations:

This study will adhere to ethical principles outlined in the Declaration of Helsinki. Informed consent will be obtained from all participants, and measures will be taken to ensure participant confidentiality and privacy.

Data Management:

Data will be collected using secure electronic data capture systems and stored in accordance with institutional guidelines and data protection regulations.

Eligibility criteria: Inclusion Criteria:

* Adults aged 60 years and older.
* Individuals living in the community.
* Mild to moderate psychological distress.

Exclusion Criteria:

* Severe cognitive impairment or dementia.
* Significant medical or psychiatric comorbidities that could impede participation in the intervention.
* Inability to understand and communicate in the language used for the intervention materials.
* Concurrent participation in another research study involving psychological interventions.

Primary outcomes:
measure: Psychological Well-being Assessment
timeFrame: Psychological well-being will be assessed at baseline, prior to the intervention, and at follow-up assessments conducted at 1 months post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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