Clinical trial NCT04725526: Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management.
Official title: Development and Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management of the Multi-pathological Patient With Heart Failure: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Multi-pathology
Keywords: mHealth intervention
Lead sponsor: Instituto de investigación e innovación biomédica de Cádiz
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Health literacy
timeFrame: 1 year
measure: General selfmanagement
timeFrame: 1 year
measure: selfmanagement on heart failure
timeFrame: 1 year
Secondary outcomes:
measure: self-independence
timeFrame: 1 year
measure: self-independence 2
timeFrame: 1 year
measure: Adherence to treatments
timeFrame: 1 year
measure: Prognosis
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
measure: Patient satisfaction 2
timeFrame: 1 year
Other outcomes:
Locations:
city: Algeciras
country: Spain
facility: Health Management area of Gibraltar
state: Cádiz
city: Cadiz
country: Spain
facility: F. para la Gestión de la Inv. Biomédica de Cádiz Ríos
Study officials:
affiliation: Instituto de investigación e innovación biomédica de Cádiz
name: Pilar Bas Sarmiento, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de investigación e innovación biomédica de Cádiz
name: Martina Fernández Gutiérrez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.