Heart FailurePBS-MHE-2019NCT04725526
Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management.
A study testing Mobile phone compatible with iOS or Android in people with Heart Failure and Multi-pathology, run by Instituto de investigación e innovación biomédica de Cádiz at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Multi-pathology
- What is being tested?
- Mobile phone compatible with iOS or Android
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Mar 2020to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 1 recruiting
- Active, not recruiting
Health Management area of Gibraltar
Algeciras, Cádiz, 11207
- Recruiting
F. para la Gestión de la Inv. Biomédica de Cádiz Ríos
Cadiz, 11009
F. para la Gestión de la Inv. Biomédica de Cádiz Ríos, 653350589, laura.quintana@inibica.es
About this study
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.
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.
Read the 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.
- Conditions
- Heart Failure, Multi-pathology
- Being tested
- Mobile phone compatible with iOS or Android
- Keywords
- mHealth intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone compatible with iOS or AndroidDevice
MHealth (mobile health) intervention is an act whose purpose is to improve, maintain, promote or modify health, functioning or health conditions.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Mobile phone compatible with iOS or Android |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy
Literacy on health defined by points (range 0-50)
Measured: 1 year
General selfmanagement
Selfmanagement on health (scale 1-5)
Measured: 1 year
selfmanagement on heart failure
European Heart Failure SelfCare Behavior Scale (range 12-60)
Measured: 1 year
Secondary outcomes (6)
self-independence
Personal grade of self-independence- Barthel Index
Measured: 1 year
self-independence 2
Personal grade of self-independence- Lawton and Brody Index
Measured: 1 year
Adherence to treatments
Adherence to treatments measured by Morisky-Green Questionnaire
Measured: 1 year
Prognosis
Life prognosis using PROFUND Index
Measured: 1 year
Patient satisfaction
General patient satisfaction using a simple questionnarie
Measured: 1 year
Patient satisfaction 2
Patients satisfaction related to mHealth device
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Mar 2020
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de investigación e innovación biomédica de Cádiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pilar Bas Sarmiento, MD, Principal investigator, Instituto de investigación e innovación biomédica de CádizMartina Fernández Gutiérrez, Principal investigator, Instituto de investigación e innovación biomédica de Cádiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725526
- Sponsor's protocol ID
- PBS-MHE-2019
- Acronym
- PBS-MHE-2019
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2020
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35486437
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04725526
- Acronym / sponsor ID
- PBS-MHE-2019 / PBS-MHE-2019
- Conditions
- Heart Failure, Multi-pathology
- Keywords
- mHealth intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Instituto de investigación e innovación biomédica de CádizUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Mobile phone compatible with iOS or AndroidA group of pluripatological patients with heart failure and complex needs of health will be tratad per standard of care plus mHealth intervention on site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile phone compatible with iOS or AndroidMHealth (mobile health) intervention is an act whose purpose is to improve, maintain, promote or modify health, functioning or health conditions. | Device | mHealth intervention plus usual clinical practice |
Primary outcome
Health literacy
Time frame: 1 year
Literacy on health defined by points (range 0-50)
General selfmanagement
Time frame: 1 year
Selfmanagement on health (scale 1-5)
selfmanagement on heart failure
Time frame: 1 year
European Heart Failure SelfCare Behavior Scale (range 12-60)
6 secondary outcomes
self-independence
Time frame: 1 year
self-independence 2
Time frame: 1 year
Adherence to treatments
Time frame: 1 year
Prognosis
Time frame: 1 year
Patient satisfaction
Time frame: 1 year
Patient satisfaction 2
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Derived from this study: PubMed 35486437Bas-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Bas Sarmiento, MD principal investigator
Instituto de investigación e innovación biomédica de Cádiz
Martina Fernández Gutiérrez principal investigator
Instituto de investigación e innovación biomédica de Cádiz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone compatible with iOS or Android in people with Heart Failure and Multi-pathology, run by Instituto de investigación e innovación biomédica de Cádiz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Quintana, phD (639390856, laura.quintana@inibica.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health literacy (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.