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

NCT ID: NCT04725526

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-01-01

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.

Detailed 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.

Conditions

Heart Failure; Multi-pathology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

usual clinical practice

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

mHealth intervention plus usual clinical practice

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

Group Type: EXPERIMENTAL

Mobile phone compatible with iOS or Android

Intervention Type: DEVICE

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

Interventions

Mobile phone compatible with iOS or Android

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de investigación e innovación biomédica de Cádiz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pilar Bas Sarmiento, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto de investigación e innovación biomédica de Cádiz

Martina Fernández Gutiérrez

Role: PRINCIPAL_INVESTIGATOR

Instituto de investigación e innovación biomédica de Cádiz

Locations

Health Management area of Gibraltar

Algeciras, Cádiz, Spain

Site Status: ACTIVE_NOT_RECRUITING

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

Cadiz, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Laura Quintana, phD

Role: CONTACT

laura.quintana@inibica.es

639390856

Facility Contacts

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

Role: primary

laura.quintana@inibica.es

653350589

References

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.

Reference Type: DERIVED

PMID: 35486437 (View on PubMed)

Other Identifiers

PBS-MHE-2019

Identifier Type: -

Identifier Source: org_study_id