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临床试验/NCT04411355
NCT04411355已完成不适用

Nursing Management in Patients With Hypertension

Ege University0 个研究点目标入组 30 人开始时间: 2012年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
The Patient Assessment of Chronic Illness Care (PACIC)

研究概览

简要总结

Background: This study was conducted to examine the effect of planned educational intervention based on The Chronic Care Model (CCM) on the management of hypertension in patients with hypertension. The Chronic Care Model is a framework for organizing and improving chronic illness care, based on a proactive, planned approach that incorporates patient self-care, provider, and system level interventions. Several instruments have been developed to evaluate the effects of CCM implementation on care and treatment outcomes.The Patient Assessment of Chronic Illness Care (PACIC) questionnaire is used in instrument to evalate the delivery of care for patients.

Methods: The study was performed a prospective and conducted with a controlled semi-experimental pattern in matched groups. 30 patients including 15 intervention and 15 control group patients matched in terms of socio-demographic features were monitored for six months. The intervention group was trained and monitored by a professional team in line with the components of the model. Life quality scale, hypertension information questions and chronic care assessment scale were applied to both groups at the beginning and in the sixth month of the study.

Trial registration: The study was conducted in accordance with the World Medical Association Declaration of Helsinki of 1964, and approved by local authorities and local Bioethics Committees(BC) in participating university hospital. (Ethics committee approval No:B.30.2.EGE.0.20.05.00/OY/649/268 Decision No: 13-3.3/12) Permissions for the use of scale of PACIC and model of CCM were taken via e-mail.

Key Words: nursing; chronic care model; hypertension

详细描述

According to the World Health Organisation, 60% of all deaths in the world result from chronic illnesses, and 80% of these deaths occur in low and middle income countries (WHO 2008a).One of the most common chronic illnesses is hypertension, and it affects almost 20% of the adult population. The fact that chronic diseases have become widespread nowadays reveals the importance of chronic disease control and community-based disease management programs (Cranston 2006). Chronic disease management includes the treatment of the disease and preparing and strengthening the patients to help patients to gain self-management skills. With an effective disease management; symptoms, recourses to emergency units and hospitalisation can be reduced, physiological and psychological effects of the disease can be limited, dependence can be prevented, and life quality can be enhanced (Haskett 2006). Among the models of chronic disease management, the most well-known, the most frequently used and the most effective one is "Chronic Care Model"(CCM) (Piat et al. 2007). Since social and economic burden has gradually increased in chronic care management, "CCM" was presented as a guide with the aim of enhancing the quality of the care and reducing the care costs (Geyman 2007). The main point of the model identified by Wagner et al. is the "existence of a fruitful interaction between the health care team and the patient" (Rothman & Wagner 2003, Solberg et al. 2005). According to the model, the "patient" motivated by a relation of knowledge, skill and trust and the "health care team" having the necessary expertise, knowledge and sources can take effective decisions for a high quality care and conduct an effective chronic disease care management by using the available sources (ICN 2010, Wagner 2001). This research was conducted to evaluate the effects of the use of the CCM in patients with hypertension on life quality and clinic results and to conduct a study concerning the use of this model in the chronic diseases in Turkey.

METHODS Research Design:The research was conducted in the nephrology polyclinic of a university hospital for six months with a controlled semi-experimental design in matched groups.

Population and sample:Population of the research consisted of all patients who applied to and followed in the nephrology polyclinic. In the selection of the sample, patient files were listed by using the polyclinic records. Out of this list,2 groups were created as intervention and control group matched in consideration of socio-economic variables such as age, sex and educational background. According to the power-analysis method, 15 intervention and 15 control group patients constituted the sample of the research. The power of the study was determined as 90% in p=0,05 reliability coefficient .

Data collection tools:In collecting the data, researcher used the socio-demographic features form prepared in consideration of the literature and expert views and the following forms for follow-up.

Attitude and habits scale concerning hypertension Information about hypertension WHOQOL-BREF(Tr) life quality assessment scale Chronic Disease Care Assessment Scale (PACIC) Hospital Anxiety and Depression Scale Integration of CCM into the study I. Organization of Health Care

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • * Being in the 18-65 age group
  • Being literate
  • No sensory losses such as vision and hearing
  • Willingness to participate in the study
  • Being open to communication and cooperation
  • Internet access and availability
  • To have a phone that can be reached
  • Having a diagnosis of hypertension at least 6 months ago
  • According to JNC-6,1997 classification, high blood pressure level is normal, stage 1,2 and 3, risk group A and B, no additional organ damage
  • Not having metabolic disturbances or diseases that prevent to from participating in the study.

排除标准

  • Not being a volunteer
  • Not complying with inclusion criteria

结局指标

主要结局

The Patient Assessment of Chronic Illness Care (PACIC)

时间窗: 6 months

The tool was developed in 2005 by Glasgow and is allowing the evaluation of health care services offered to chronic patients by patients,easy to apply,20 items short tool.PACIC,created in line with the basic 6 elements of the CCM,consists of 5 subdimensions;\*Patient Activation (items 1-3),\*Delivery System Design/Decision Support (items 4-6),\*Goal Setting (items 7-11),\*Problem-solving/Contextual Counseling (items 12-15),\*Follow-up/Coordination (items 16-20).The total score of the scale is calculated by the average score of all 20 items.The average score of each sub-dimension are measured by a 5-point Likert-type grading. The increase in scale scores indicates that individuals with chronic diseases have high satisfaction with the care patients receive and that chronic disease management is sufficient.The validity and reliability of theTurkish version of the scale was done by İncirkuş and Nahcivan(2010).

Hypertensive nephropathy

时间窗: 6 months

The reduced glomerular filtration rate (eGFR). GFR rate is calculated using a mathematical formula that compares a person's size, age, sex, and race to serum creatinine levels. A normal GFR 60 mL/min/1.73 m² .the lower the GFR number, the worse the kidney function.

WHOQOL-BREF(TR) quality of life assessment

时间窗: 6 months

The WHOQOL-BREF(TR)scale developed from WHOQOL-100 to evaluate the quality of life.The cultural adaptation of the scale inTurkey performed by Eser(1999).The Turkish versionof the scale,27th question,national environmental area has been added as"Area V"; Area I:Physical area:To be able to carry out daily tasks,dependence on drugs, treatment, vitality,fatigue,physical activity,pain,discomfortsleep,rest,ability to work. Area II:Mental area:Body image and appearance,negative emotions,memory, distraction. Area III:Social relations area:Relations with other people,social support,sexual life. Area IV:Environmental area:Financial resources,physical security,accessibility to health services,home environment,opportunity to use rest,leisure time,physical environment, transportation. Area V:National environmental area:cultural area The total score is range from a min.of 27 to a max.of 135.

次要结局

  • The indicator of perfusion to vital organs(6. month)
  • Blood glucose levels as the clinical indicator(6. month)
  • HbA1c levels as the clinical indicator(3. and 6. month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülbin Konakçı

Asst. Prof.

Ege University

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