Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management. (PBS-MHE-2019)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Multi-pathology
• Intervention / Treatment: Device: Mobile phone compatible with iOS or Android

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.

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Quintana, phD; Phone Number: 639390856; Email: laura.quintana@inibica.es

Study Locations

• Spain
  • Cadiz, Spain, 11009
    • Recruiting
    • F. para la Gestión de la Inv. Biomédica de Cádiz Ríos
    • Contact: F. para la Gestión de la Inv. Biomédica de Cádiz Ríos; Phone Number: 653350589; Email: laura.quintana@inibica.es
  • Cádiz
    • Algeciras, Cádiz, Spain, 11207
      • Active, not recruiting
      • Health Management area of Gibraltar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Experimental: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-independence	Personal grade of self-independence- Barthel Index	1 year
self-independence 2	Personal grade of self-independence- Lawton and Brody Index	1 year
Adherence to treatments	Adherence to treatments measured by Morisky-Green Questionnaire	1 year
Prognosis	Life prognosis using PROFUND Index	1 year
Patient satisfaction	General patient satisfaction using a simple questionnarie	1 year
Patient satisfaction 2	Patients satisfaction related to mHealth device	1 year

Collaborators and Investigators

• Sponsor: Instituto de investigación e innovación biomédica de Cádiz
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• Bas-Sarmiento P, Fernández-Gutiérrez M, Poza-Méndez M, Marín-Paz AJ, Paloma-Castro O, Romero-Sánchez 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: mHealth intervention
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PBS-MHE-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No