跳至主要内容
临床试验/NCT04164160
NCT04164160Unknown不适用

Effectiveness of the Integrated Care Model Salut+Social in Patients With Chronic Conditions: a Mixed Methods Study Protocol

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
141
试验地点
2
主要终点
Change in patient experience about his/her care

研究概览

简要总结

Integrated care models aim to promote the coordination and communication between services. The present study aim to evaluate the effectiveness of a new integrated care model (Salut+Social model) which will promote the coordination and communication between social and healthcare services in southern Catalonia (Spain) for the improvement of quality of life of chronic patients, adherence to treatment, access to medical services and caregiver overload. Also, we will evaluate the experience of health and social professionals with the new model implemented.

详细描述

A clinical trial with mixed methodology will be carried out. The intervention consists of the promotion and coordination between the social and health sectors, for 6 months, through the use of information and communication technology (ICT) tools that operate as an interface for the integrated care model. The study subjects are chronic patients with health and social conditions that are susceptible to be treated in a collaborative and coordinated way in the field of primary health care. A sample size of 141 patients was estimated. Questionnaires will be used at baseline and at 6, 9 and 12 months after the beginning of the study for the evaluation of quality of life, treatment adherence, medical service and caregiver overload. The principal variable is the quality of life. For statistical analysis, comparisons of means and proportions at different time points will be performed. One discussion group will be performed with the aim of improving the care model according to professionals' opinions. A thematic content analysis will be carried out.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult patients with at least one health and one social condition, as below specified:
  • health condition, according to diagnosis of the electronic medical history: complex chronic patient; advanced chronic disease; patient in the home care program; dementia; neurodegenerative diseases; stroke; others chronic disease.
  • social condition, according to social service workstation from Ribera d'Ebre district: dependence grade; home social service assistance; teleassistance systems assigned by home support.
  • Knowledgement of Spanish or Catalan.
  • Accepting participation in the study (with informed consent signed by the patient or by the caregiver).

排除标准

  • Institutionalized patients.
  • Users with difficulties filling out or respond a questionnaire.

结局指标

主要结局

Change in patient experience about his/her care

时间窗: change from IEXPAC at 6, 9 and 12 months after the beginning of the study

Be evaluated with the IEXPAC (Instrument for the Evaluation of the Chronic Patient's Experience). Each of the 11 items will be measured with 5-point Likert scale. The global punctuation is an average of the score of the each of the items: 0 (worst experience) to 10 (best experience).

Change in life quality

时间窗: change from life quality at 6, 9 and 12 months after the beginning of the study.

to be evaluated with the EuroQol- 5 Dimension (EQ-5D). It will be measured by a scale Likert: 0 (worst) to 1 (best).

Change in caregiver burden

时间窗: change from Zarit Caregiver Burden Inventory at 6, 9 and 12 months after the beginning of the study.

to be evaluated with the Zarit Caregiver Burden Inventory. It will be measured by a scale Likert: 22 (best) to 110 (worst).

Change in adherence to treatment

时间窗: change from Morisky and Green test at 6, 9 and 12 months after the beginning of the study.

be evaluated with the Morisky and Green test. It will be measured with a dichotomic variable: compliant (if response for the 4 questions is: No/Yes/No/No); noncompliant (if response for the 4 questions is different for: No/Yes/No/No).

次要结局

  • Sociodemographic characteristics of the patients(baseline (pre intervention period))
  • Caregiver characteristics: caregiver relationship(baseline (pre intervention period))
  • Caregiver characteristics: hours of support(baseline (pre intervention period))
  • Caregiver characteristics: caregiver with family relationship(baseline (pre intervention period))

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Sponsor

研究点 (2)

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