Development and Evaluation of a Multimodal Approach to Nursing Care (MANC) Module Versus Traditional Practice of Family Caregivers for Patients of Cerebrovascular Accident Discharged from a Tertiary Care Hospital.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Reduction in caregiver stress and burden.
研究概览
简要总结
This study aims to evaluate the effectiveness of a Multimodal Approach to Nursing Care (MANC) Module compared to traditional caregiving practices among family caregivers of patients discharged after cerebrovascular accident (stroke). The MANC intervention includes structured education on stroke management, medical device care, psychological support, and progressive muscle relaxation (PMR) sessions delivered over a 12-week period. The hypothesis is that caregivers receiving the MANC Module will show significantly greater improvements in stress reduction, caregiving knowledge, self-efficacy, and quality of life, as compared to those receiving standard care alone. The study follows a randomized controlled trial design with 194 participants, divided equally between intervention and control arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Family caregivers who are the primary caregivers of patients diagnosed with neurological disorders.
- •Caregivers of patients who have been discharged with specific medical devices such as Foley catheters or nasogastric (NG) tubes.
- •Caregivers aged 18 years or older.
- •Caregivers who provide direct care to the patient at home after discharge.
- •Caregivers who are willing to participate in the multimodal intervention, including educational support, and Progressive muscle Relaxation (PMR) techniques.
- •Caregivers who provide written informed consent to participate in the study.
排除标准
- •Caregivers who are healthcare professionals (e.g., nurses, therapists) providing care outside of their professional capacity.
- •Caregivers of patients who have additional severe co-morbid conditions that may require specialized care beyond the scope of the study.
- •Caregivers who are unwilling to participate in Progressive muscle Relaxation (PMR) techniques or other components of the multimodal intervention.
- •Caregivers who do not speak the language in which the intervention is delivered and cannot comprehend the study materials.
- •Caregivers who reside far from the hospital make regular follow-up and intervention participation impractical.
- •who are currently enrolled in other clinical trials or research studies that may confound the outcomes of the present study.
结局指标
主要结局
Reduction in caregiver stress and burden.
时间窗: Baseline at 6week and after 12 week
Caregiver knowledge and competence
时间窗: Baseline at 6week and after 12 week
次要结局
- Caregiver Self-Efficacy in Device management(Baseline and after 12th week)
- Caregiver Quality of Life(Baseline and after 12th week)
- Patient Health Outcome(Baseline and after 12th week)
- Feedback(satisfaction with MANC module)
研究者
Patricia Santosh Reddy
Shrimati Radhikabai Meghe Memorial College of Nursing