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

Heart Failure Clinical Trial

— PBS-MHE-2019  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725526
• Other study ID #: PBS-MHE-2019
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2021
• Source: Instituto de investigación e innovación biomédica de Cádiz
• Contact: Laura Quintana, phD
• Phone: 639390856
• Email: laura.quintana[@]inibica.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure
• Multi-pathology

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Health Management area of Gibraltar	Algeciras	Cádiz
Spain	F. para la Gestión de la Inv. Biomédica de Cádiz Ríos	Cadiz

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de investigación e innovación biomédica de Cádiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health literacy	Literacy on health defined by points (range 0-50)	1 year
Primary	General selfmanagement	Selfmanagement on health (scale 1-5)	1 year
Primary	selfmanagement on heart failure	European Heart Failure SelfCare Behavior Scale (range 12-60)	1 year
Secondary	self-independence	Personal grade of self-independence- Barthel Index	1 year
Secondary	self-independence 2	Personal grade of self-independence- Lawton and Brody Index	1 year
Secondary	Adherence to treatments	Adherence to treatments measured by Morisky-Green Questionnaire	1 year
Secondary	Prognosis	Life prognosis using PROFUND Index	1 year
Secondary	Patient satisfaction	General patient satisfaction using a simple questionnarie	1 year
Secondary	Patient satisfaction 2	Patients satisfaction related to mHealth device	1 year