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

NCT04725526 | Unknown

• 1 other identifier: PBS-MHE-2019
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure; Multi-pathology

Keywords

mHealth intervention

Outcome Measures

Primary Outcomes (3)

• Health literacy

  Literacy on health defined by points (range 0-50)

  1 year

• General selfmanagement

  Selfmanagement on health (scale 1-5)

  1 year

• selfmanagement on heart failure

  European Heart Failure SelfCare Behavior Scale (range 12-60)

  1 year

Secondary Outcomes (6)

• self-independence

  1 year

• self-independence 2

  1 year

• Adherence to treatments

  1 year

• Prognosis

  1 year

• Patient satisfaction

  1 year

Study Arms (2)

usual clinical practice

NO INTERVENTION

A group of pluripatological patients with heart failure and complex needs of health will be tratad per standard of care on site

mHealth intervention plus usual clinical practice

EXPERIMENTAL

A group of pluripatological patients with heart failure and complex needs of health will be tratad per standard of care plus mHealth intervention on site

Device: Mobile phone compatible with iOS or Android

Interventions

Mobile phone compatible with iOS or Android DEVICE

MHealth (mobile health) intervention is an act whose purpose is to improve, maintain, promote or modify health, functioning or health conditions.

mHealth intervention plus usual clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes and over 18 years of age;
• Attended by the health professionals of the Basic Health Areas that are participating in the study;
• Patients that give their consent to participate in the study by signing an informed consent;
• Patients that have a mobile device (Smartphone or Tablet) compatible with the Android or iOS operating system;
• Patients considered as multi-pathological based on the following criteria from those described 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 be simultaneously classified, or not, in other clinical categories due to suffering from another 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 on the Gijon scale greater than 10 points); Stage II or higher pressure ulcers; Malnutrition (BMI \<18.5); Feeding with chronic and prescription tube (3 or more months); Two or more hospital admissions in the previous 12 months.

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de investigación e innovación biomédica de Cádiz: lead

Study Sites (2)

Health Management area of Gibraltar

Algeciras, Cádiz, 11207, Spain

ACTIVE NOT RECRUITING

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

Cadiz, 11009, Spain

RECRUITING

Related Publications (1)

• Bas-Sarmiento P, Fernandez-Gutierrez M, Poza-Mendez M, Marin-Paz AJ, Paloma-Castro O, Romero-Sanchez JM; ASyAG_PPIC Team. Development and Effectiveness of a Mobile Health Intervention in Improving Health Literacy and Self-management of Patients With Multimorbidity and Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 29;11(4):e35945. doi: 10.2196/35945.

  PMID: 35486437 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Pilar Bas Sarmiento, MD

  Instituto de investigación e innovación biomédica de Cádiz

  PRINCIPAL INVESTIGATOR

• Martina Fernández Gutiérrez

  Instituto de investigación e innovación biomédica de Cádiz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Quintana, phD

CONTACT

639390856; laura.quintana@inibica.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: January 26, 2021
• Study Start: March 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: August 8, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)