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

Primary Purpose

Heart Failure, Multi-pathology

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mobile phone compatible with iOS or Android
Sponsored by
Instituto de investigación e innovación biomédica de Cádiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring mHealth intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Health Management area of Gibraltar
  • F. para la Gestión de la Inv. Biomédica de Cádiz RíosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

usual clinical practice

mHealth intervention plus usual clinical practice

Arm Description

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

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

Outcomes

Primary Outcome Measures

Health literacy
Literacy on health defined by points (range 0-50)
General selfmanagement
Selfmanagement on health (scale 1-5)
selfmanagement on heart failure
European Heart Failure SelfCare Behavior Scale (range 12-60)

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2020
Last Updated
August 5, 2022
Sponsor
Instituto de investigación e innovación biomédica de Cádiz
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1. Study Identification

Unique Protocol Identification Number
NCT04725526
Brief Title
Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de investigación e innovación biomédica de Cádiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Multi-pathology
Keywords
mHealth intervention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
usual clinical practice
Arm Type
No Intervention
Arm Description
A group of pluripatological patients with heart failure and complex needs of health will be tratad per standard of care on site
Arm Title
mHealth intervention plus usual clinical practice
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Mobile phone compatible with iOS or Android
Intervention Description
MHealth (mobile health) intervention is an act whose purpose is to improve, maintain, promote or modify health, functioning or health conditions.
Primary Outcome Measure Information:
Title
Health literacy
Description
Literacy on health defined by points (range 0-50)
Time Frame
1 year
Title
General selfmanagement
Description
Selfmanagement on health (scale 1-5)
Time Frame
1 year
Title
selfmanagement on heart failure
Description
European Heart Failure SelfCare Behavior Scale (range 12-60)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
self-independence
Description
Personal grade of self-independence- Barthel Index
Time Frame
1 year
Title
self-independence 2
Description
Personal grade of self-independence- Lawton and Brody Index
Time Frame
1 year
Title
Adherence to treatments
Description
Adherence to treatments measured by Morisky-Green Questionnaire
Time Frame
1 year
Title
Prognosis
Description
Life prognosis using PROFUND Index
Time Frame
1 year
Title
Patient satisfaction
Description
General patient satisfaction using a simple questionnarie
Time Frame
1 year
Title
Patient satisfaction 2
Description
Patients satisfaction related to mHealth device
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Quintana, phD
Phone
639390856
Email
laura.quintana@inibica.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar Bas Sarmiento, MD
Organizational Affiliation
Instituto de investigación e innovación biomédica de Cádiz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martina Fernández Gutiérrez
Organizational Affiliation
Instituto de investigación e innovación biomédica de Cádiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Management area of Gibraltar
City
Algeciras
State/Province
Cádiz
ZIP/Postal Code
11207
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
F. para la Gestión de la Inv. Biomédica de Cádiz Ríos
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F. para la Gestión de la Inv. Biomédica de Cádiz Ríos
Phone
653350589
Email
laura.quintana@inibica.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35486437
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. Erratum In: JMIR Res Protoc. 2022 Dec 7;11(12):e44570.
Results Reference
derived

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

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