An Integrated Care Model for Chronic Patients

March 19, 2020 updated by: Jordi Gol i Gurina Foundation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Tarragona
      • Tortosa, Tarragona, Spain, 43500
        • Recruiting
        • Institut Català de la Salut
        • Contact:
          • Alessandra Q Gonçalves, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with at least one health and one social condition, as below specified:

    1. 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.
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: integrated-care-model benefiting group
Chronic patients whose clinical and social data will be added in the integrated care model application software.
Other: integrated-care-model benefiting group
Patients will be called for the first interview of the study by the healthcare professional. Their data will be automatically entered in the Salut + Social app, they will be asked to respond to the study questionnaires (ad hoc questionnaire for sociodemographic data, EuroQol-5D, Zarit questionnaire and Morisky-Green test) and will take part in the future actions to be planned for them. Patients will receive an appointment to attend their PCC at 6, 9, and 12 months after their incorporation into the program. In those follow-up, the same questionnaires will be provided together with the IEXPAC questionnaire, which evaluates the experience of the chronic patient with the new care model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from life quality at 6, 9 and 12 months after the beginning of the study.
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 from Zarit Caregiver Burden Inventory at 6, 9 and 12 months after the beginning of the study.
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).
change from Morisky and Green test at 6, 9 and 12 months after the beginning of the study.
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 from IEXPAC at 6, 9 and 12 months after the beginning of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic characteristics of the patients
Time Frame: baseline (pre intervention period)
age, sex, level of education, civil status, job situation, nationality
baseline (pre intervention period)
Caregiver characteristics: caregiver with family relationship
Time Frame: baseline (pre intervention period)
To be evaluated with an ad hoc questionnaire (yes/no type)
baseline (pre intervention period)
Caregiver characteristics: caregiver relationship
Time Frame: baseline (pre intervention period)
To be evaluated with an ad hoc questionnaire (1. Couple; 2. Mother; 3. Father; 4. Son; 5. Others).
baseline (pre intervention period)
Caregiver characteristics: hours of support
Time Frame: baseline (pre intervention period)
To be evaluated with an ad hoc questionnaire (quantitative variable).
baseline (pre intervention period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordi Gol i Gurina Foundation

Collaborators

Institut Català de la Salut
Department of Health, Generalitat de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ANTICIPATED)

June 30, 2020

Study Completion (ANTICIPATED)

June 30, 2020

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (ACTUAL)

November 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7Z18/020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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