Investigation of the Effect of Nurse Counseling According to the Chronic Care Model on Symptom Status, Stress and Quality of Life in Individuals With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Symptom status will be evaluated using the Inflammatory Bowel Disease Disease Activity Index .This scale measures disease activity and associated symptoms.
研究概览
简要总结
This study aims to evaluate the effects of nurse counseling provided based on the Chronic Care Model on symptom status, stress, and quality of life in individuals diagnosed with Inflammatory Bowel Disease (IBD).
详细描述
nflammatory Bowel Diseases (IBD), comprising a group of chronic disorders characterized by recurrent inflammation of the gastrointestinal tract, are associated with an irregular and inappropriate immune response to intestinal flora. These diseases, which manifest with periods of remission and relapse, are classified into Ulcerative Colitis (UC), Crohn's Disease (CD), and Indeterminate Colitis (IC), where clinical differentiation between UC and CD is not clear. While the inflammatory response in UC is confined to the mucosa and submucosa, in CD, the inflammation extends through the entire intestinal wall, from the mucosa to the serosa. CD most commonly affects the distal small intestine and colon, but it can occur segmentally at any site along the gastrointestinal tract, from the mouth to the anus. Conversely, UC inflammation is typically limited to the colon and presents as diffuse superficial involvement without skipping intact segments. In some IBD cases, distinguishing between CD and UC is challenging, leading to a diagnosis of IC. These diseases demand attention due to their chronic nature and significant utilization of healthcare resources. Globally, approximately 11.2 million people are affected by IBD, with higher prevalence reported in Europe and North America. In Turkey, the incidence of IBD is reported as 2.6 per 100,000 for UC and 1.4 per 100,000 for CD.
IBD symptoms can be intestinal (gastrointestinal in origin) or extra-intestinal, resulting from associated autoimmune disorders or external manifestations of the disease. The symptoms vary depending on the activity and localization of the disease. While the major symptoms in UC and CD overlap, the severity of these symptoms differs based on the intensity of the disease. Intestinal symptoms such as diarrhea, fever, severe fatigue, abdominal pain and cramping, bloody stool, tenesmus, appetite loss, and weight loss, as well as extra-intestinal symptoms affecting various systems, can manifest with different severities in each patient. Fourie, Jackson, and Aveyard, in their review of 23 qualitative studies, highlighted fatigue, incontinence, uncertainty about the future, body image issues, and insufficient information from healthcare providers as dominant experiences among patients living with IBD.
Nurses play a crucial role in educating and empowering individuals with IBD to develop and utilize self-management skills and strategies to overcome disease-related challenges . IBD is well-suited for technological interventions, which can enhance care by involving, educating, and monitoring patients while addressing the unique manifestations of the disease in each individual.
Quality of life is a significant patient outcome indicator in both observational and interventional studies within the IBD literature . These two disease groups, characterized by periods of relapse and remission, significantly impact patients biopsychosocially, leading to disabilities and reduced quality of life. The medical management of IBD aims not only to alleviate disease symptoms but also to enhance patients' overall well-being and improve their quality of life. A study by Jelsness-Jørgensen et al. demonstrated that patient follow-up led by IBD nurses significantly improved quality-of-life scores over a year compared to traditional follow-up. Similarly, Del Hoyo et al. found that quality of life, social activity, and satisfaction levels improved across three patient groups (remotely monitored, nurse-supported telephone care, and standard face-to-face care). Effective multidisciplinary care is key to delaying relapse, prolonging remission, managing complications, and enhancing quality of life. Nurses, as part of the multidisciplinary team, play a pivotal role in supporting patients effectively in care settings outside the hospital. With appropriate management and support, they can ensure patients remain at the center of care.
Psychological comorbidities such as anxiety, depression, somatization, and perceived stress are associated with IBD, persisting not only during active disease phases but also in the absence of inflammation due to ongoing symptoms. Acute psychological issues, particularly, can exacerbate symptoms in individuals with UC by inducing systemic and mucosal pro-inflammatory responses, thereby negatively impacting the emotional dimension of quality of life in IBD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study involved concrete concepts such as counseling and education, making it impossible to blind participants and researchers. However, the statistical analyses of the data were conducted by a statistics expert, and blinding was achieved during the statistical analysis phase since the groups were identified only by numbers.
入排标准
- 年龄范围
- 12 Weeks 至 12 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Individuals diagnosed with IBD who agree to participate in the study will be included after written informed consent form and informed consent form are obtained.
- •Have a confirmed diagnosis of IBD at least 6 months ago,
- •No obstacles to communication,
- •Can use a smartphone,
- •It will be determined from volunteers who agree to participate in the research on a voluntary basis.
排除标准
- •- IBHs for whom written consent cannot be obtained will be excluded from the study.
- •Those who wish to leave the research without completing the research with their own consent,
- •Patients who cannot have at least 3 interviews,
- •Patients who do not show up for the appointment for the final test will not be included.
结局指标
主要结局
Symptom status will be evaluated using the Inflammatory Bowel Disease Disease Activity Index .This scale measures disease activity and associated symptoms.
时间窗: 12 weeks
the impact of nursing counseling, in the patient before in Symptom Status
Stress levels will be assessed using the Perceived Stress Scale (PSS-14). The PSS-14 evaluates perceived stress levels in daily life and how individuals cope with stress.
时间窗: 12 weeks
the impact of nursing counseling, in the patient before and after on the stress levels
Quality of life will be assessed using the Inflammatory Bowel Disease Quality of Life scale. Changes in quality of life scores will be evaluated over time to determine improvements.
时间窗: 12 weeks
the impact of nursing counseling, in the patient before and after in Quality of Life
次要结局
未报告次要终点
研究者
Seval AKBEN
Lecturer
Hasan Kalyoncu University
