Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management.

Last updated: August 5, 2022
Sponsor: Instituto de investigación e innovación biomédica de Cádiz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT04725526
PBS-MHE-2019
  • Ages > 18
  • All Genders

Study Summary

Multipathological patients with complex health needs are responsible for the majority number of avoidable hospital admissions.

The expansion of mHealth interventions in the field of communication with the patient, the reduction of health inequalities, the improvement in access to health resources, the adherence to treatments and self-care of chronic diseases lead to an optimistic horizon . However, there are few applications that demonstrate its effectiveness in these patients, which is diminished when they are not based on evidence, nor are designed by and for users with different levels of health literacy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of both sexes and over 18 years of age;
  • Attended by the health professionals of the Basic Health Areas that are participatingin the study;
  • Patients that give their consent to participate in the study by signing an informedconsent;
  • Patients that have a mobile device (Smartphone or Tablet) compatible with the Androidor iOS operating system;
  • Patients considered as multi-pathological based on the following criteria from thosedescribed in the Integrated Healthcare Process (Ollero et al., 2018):
  • Be classified in clinical category A of chronic pathologies due to heart failure that,in a situation of clinical stability, has been in NYHA grade II, being able to besimultaneously classified, or not, in other clinical categories due to suffering fromanother disease Chronicles.
  • Patients with at least one of the following complexity criteria: Extreme polypharmacy (10 or more active ingredients for chronic prescription); Socio-family risk (score onthe Gijon scale greater than 10 points); Stage II or higher pressure ulcers;Malnutrition (BMI <18.5); Feeding with chronic and prescription tube (3 or moremonths); Two or more hospital admissions in the previous 12 months.

Exclusion

Exclusion Criteria:

  • Patients with sensory deficits and/or mobility problems in the upper limbs thatprevent them from using the application correctly, despite using the accessibilityfeatures of mobile devices;
  • Patients with persistent cognitive impairment (Pfeiffer test with 5 or more errors orLobo's mini-cognitive exam <23 points) and / or severe mental disorder;
  • Patients with serious limitations for AVBD (Barthel index <20 points).

Study Design

Total Participants: 236
Study Start date:
March 01, 2020
Estimated Completion Date:
January 01, 2024

Study Description

Objective: to evaluate the efficacy of an mHealth intervention, with respect to routine clinical practice, to improve health literacy and self-management of the multiple pathological patient with heart failure and complex health needs.

Hypothesis: the proposed mHealth intervention is more effective than usual clinical practice, favoring health literacy and self-management of multiple pathological patients with heart failure and complex health needs, so its use would be relevant as part of the assistance process.

Methodology: randomized, controlled, multicenter clinical trial for the evaluation of the efficacy of an mHealth intervention with two groups: a control group (routine clinical practice) and an experimental group (routine clinical practice together with ad hoc designed mHealth intervention).

In this project, the design and content validation of the mHealth tool will be carried out, evaluating its relevance and suitability.

Connect with a study center

  • Health Management area of Gibraltar

    Algeciras, Cádiz 11207
    Spain

    Site Not Available

  • F. para la Gestión de la Inv. Biomédica de Cádiz Ríos

    Cadiz, 11009
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta del Mar

    Cádiz, 11009
    Spain

    Site Not Available

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