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Clinical Trials/NCT04164160
NCT04164160
Unknown
Not Applicable

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 Gurina1 site in 1 country141 target enrollmentJune 1, 2019
ConditionsIntegrated Care

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Integrated Care
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
141
Locations
1
Primary Endpoint
Change in patient experience about his/her care
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
June 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in patient experience about his/her care

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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).

Secondary Outcomes

  • 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))

Study Sites (1)

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