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Integrated CareNCT04164160

An Integrated Care Model for Chronic Patients

A study testing integrated-care-model benefiting group in people with Integrated Care, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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)… Read more about this study

Who is it for?
Any age
Conditions the study is for
Integrated Care
What is being tested?
integrated-care-model benefiting group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
1 siteSpain
Study dates
1 Jun 2019to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pere M Zaragoza, BSc contact

+34 934824253

pmonteagudo@idiapjgol.org

Alessandra Q Gonçalves, PhD contact

+34 977504949 ext. 4131

aqueiroga@idiapjgol.info

Spain1 site, 1 recruiting

  • Institut Català de la Salut

    Tortosa, Tarragona, 43500

    Alessandra Q Gonçalves, PhD

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
Integrated Care
Being tested
integrated-care-model benefiting group
Keywords
Integrated care, Health and social care, Chronic disease, Primary Health Care, Quality of life
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • integrated-care-model benefiting groupOther

    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.

Study groups in NCT04164160
Study groupRoleWhat they receive
integrated-care-model benefiting groupExperimentalChronic patients whose clinical and social data will be added in the integrated care model application software.
Receives: Other: integrated-care-model benefiting group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in life quality

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

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

  2. Change in caregiver burden

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

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

  3. Change in adherence to treatment

    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).

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

  4. Change in patient experience about his/her care

    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).

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

Secondary outcomes (4)

  1. Sociodemographic characteristics of the patients

    age, sex, level of education, civil status, job situation, nationality

    Measured: baseline (pre intervention period)

  2. Caregiver characteristics: caregiver with family relationship

    To be evaluated with an ad hoc questionnaire (yes/no type)

    Measured: baseline (pre intervention period)

  3. Caregiver characteristics: caregiver relationship

    To be evaluated with an ad hoc questionnaire (1. Couple; 2. Mother; 3. Father; 4. Son; 5. Others).

    Measured: baseline (pre intervention period)

  4. Caregiver characteristics: hours of support

    To be evaluated with an ad hoc questionnaire (quantitative variable).

    Measured: baseline (pre intervention period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2019
  2. Study start1 Jun 2019
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Jun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
141 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04164160
Sponsor's protocol ID
7Z18/020
Status last verified
Oct 2019
First submitted
13 Nov 2019
Last updated
23 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gavalda-Espelta E, Del Mar Lleixa-Fortuno M, Baucells-Lluis J, Ferre-Ferrate M, Mora-Lopez G, Tomas-Navarro B, Curto-Romeu C, Lucas-Noll J, Aguilar Martin C, Goncalves AQ, Ferre-Grau C. Effectiveness of the integrated care model Salut+Social in patients with chronic conditions: A mixed methods study protocol. Medicine (Baltimore). 2020 May;99(19):e19994. doi: 10.1097/MD.0000000000019994.

    PubMed 32384454

Questions about this trial

What is this clinical trial studying?

A study testing integrated-care-model benefiting group in people with Integrated Care, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pere M Zaragoza, BSc (+34 934824253, pmonteagudo@idiapjgol.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in life quality (time frame: change from life quality at 6, 9 and 12 months after the beginning of the study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04164160, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.

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