NCT04164160

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

March 23, 2020

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

November 13, 2019

Last Update Submit

March 19, 2020

Conditions

Keywords

Integrated careHealth and social careChronic diseasePrimary Health CareQuality of life

Outcome Measures

Primary Outcomes (4)

  • 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).

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

  • 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).

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

  • 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).

    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

    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 Outcomes (4)

  • Sociodemographic characteristics of the patients

    baseline (pre intervention period)

  • Caregiver characteristics: caregiver with family relationship

    baseline (pre intervention period)

  • Caregiver characteristics: caregiver relationship

    baseline (pre intervention period)

  • Caregiver characteristics: hours of support

    baseline (pre intervention period)

Study Arms (1)

integrated-care-model benefiting group

EXPERIMENTAL

Chronic patients whose clinical and social data will be added in the integrated care model application software.

Other: integrated-care-model benefiting group

Interventions

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.

integrated-care-model benefiting group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Català de la Salut

Tortosa, Tarragona, 43500, Spain

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Pere M Zaragoza, BSc

CONTACT

Alessandra Q Gonçalves, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 15, 2019

Study Start

June 1, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

March 23, 2020

Record last verified: 2019-10

Locations