跳至主要内容
临床试验/NCT02382081
NCT02382081已完成不适用

A Randomized Control Trial of Patient-initiated Hospital Follow-up for Patients With Psoriasis

University Hospital, Gentofte, Copenhagen2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Dermatology life quality index (DLQI)

研究概览

简要总结

The primary objective of this research protocol is to evaluate the health related quality of life and efficacy of patient-initiated hospital follow-up for patients with moderate to severe psoriasis.

详细描述

Psoriasis is a chronic inflammatory skin disease affecting 1 to 3% of the European population. Treatment of moderate to severe psoriasis often requires lifetime routine reviews by hospital dermatologist. Patterns of hospital review vary, but most patients attend follow-up every 12-16 week by dermatologist. At routine reviews the patient disease is often quiet and little intervention or no intervention is required, and times were the patient need help the time is limited for in-depth consultation. Both patient and healthcare professional requested more time. In-depth consultation is important in the care of psoriasis, because moderate to severe psoriasis has a significant impact on quality of life and patient have an increased incidence of cardiovascular risk factors such as hypertension, overweight, hyperlipidemia and exposure to tobacco and alcohol. These comorbidities and the psychosocial burden must be addressed by clinicians to help patients to acquire or to maintain competencies that are required to live with a chronic disease.

Patient-initiated hospital follow-up for patients with moderate to severe psoriasis might reduce inappropriate follow-up appointments, improve rapid access to specialist care and release resource to further in-depth consultation. If the patient is empowered to initiate hospital review thus patient's individual needs dictate the content, duration and contact with clinicians. It is our goal that an individual needs-based patient involvement in the shape of patient-initiated hospital follow-up,will be perceived as a benefit of the patients who 1) meets a high safety in the patient's own provision of medical treatment, 2) increase the patient's knowledge of the lifestyle and prevention of comorbidities and 3) strengths patient's overall satisfaction with treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Patients in stable systemic psoriasis treatment defined as having received treatment for more then 12 weeks without complication and being adherence to medication administration.

排除标准

  • Patients not able to give informed consent
  • Patients not able to follow the program
  • Patient with server psychiatric diseases

研究组 & 干预措施

Control

No Intervention

Traditional, routine hospital reviews every three-fourth month.

Patient-initiated shared care

Experimental

Patient-initiated shared care hospital reviews in which there were one planed hospital review every year and if needed additional reviews initiated by the patient.

Access to nurse-run telephone helpline with direct access to a contact nurse.

干预措施: Patient-initiated shared care (Procedure)

结局指标

主要结局

Dermatology life quality index (DLQI)

时间窗: 2 years

Evaluation of quality of life

次要结局

  • SF36 - Short Form 36 (SF-36)(2 years)
  • Psoriasis Area and Severity Index (PASI(2 years)
  • Hospital Anxiety and Depression Scale (HADS)(2 years)
  • Body Image Scale (BIS)(2 years)
  • Self-developed patient safety scale(2 years)
  • Hospital visits(2 years)
  • Numbers of phone calls to the nurse-run telephone helpline(2 years)
  • Adherence to medicine treatment(2 years)
  • Charlson Comorbidity Index(2 years)

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lina R. Khoury

B.N., stud.cand.scient.sant

University Hospital, Gentofte, Copenhagen

研究点 (2)

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