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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual clinical practice | No Intervention | A group of pluripatological patients with heart failure and complex needs of health will be tratad per standard of care on site | |
| mHealth intervention plus usual clinical practice | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile phone compatible with iOS or Android | Device | MHealth (mobile health) intervention is an act whose purpose is to improve, maintain, promote or modify health, functioning or health conditions. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Quintana, phD | Contact | 639390856 | laura.quintana@inibica.es |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Management area of Gibraltar | Active, not recruiting | Algeciras | Cádiz | 11207 | Spain | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35486437 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| F. para la Gestión de la Inv. Biomédica de Cádiz Ríos |
| Recruiting |
| Cadiz |
| 11009 |
| Spain |
|