mHealth ALIBIRD: A Digital Health Care Model
Study Details
Study Description
Brief Summary
The aim of this pilot study was to evaluate the feasibility and acceptability of the ALIBIRD platform, a new mobile health (mHealth) application prototype design for personalized and remote support on the follow-up of cancer patients. The ALIBIRD platform is a mHealth intervention that tracks PROs, improving symptom control and allowing real-time feedback, and provides personalized recommendations and educational content, promoting empowerment and encourage healthy lifestyle behaviors in patients with thoracic neoplasms in active treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The investigators have developed an innovative mHealth platform that provides personalized recommendations based on Patient Reported Outcomes (PROs) records and the study of patient´s nutrigenomics and gut microbiome. The usability of the ALIBIRD mHealth platform prototype is being tested in a 28-week pilot study carried out at Infanta Sofía Hospital. A small group of stage IV thoracic neoplasms patients (n=20) were asked to participate. All the participants gave informed consent.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ALIBIRD mHealth platform Participants are followed-up using the ALIBIRD mHealth platform. The ALIBIRD platform is made up of a mobile application for patients and a web application for the healthcare team. Through the ALIBIRD mobile application, patients regularly register Patients Reported Outcomes (PROs) and Patients Reported Outcome Measures (PROMs) regarding lifestyle (diet, physical activity, sleep, mood), and get access to individualized recommendations in order to assume more responsibility for achieving the best outcomes from their care. Moreover, the patient application includes features for tracking the appearance of symptoms, with alerts sent to the healthcare team in response to these parameters. In addition, the application contains articles and educational information. |
Device: ALIBIRD mHealth platform
Use of a mHealth platform to follow-up and empower cancer patients in the self-management of their own health.
|
Outcome Measures
Primary Outcome Measures
- Usability and feasibility assesment [week 1 to 28]
Changes in Satisfaction System Usability Scale (SUS)
Secondary Outcome Measures
- Changes in Mediterranean Diet Serving Score (MDSS) [Week 1 to 28]
Mediterranean adherence assesment
- Changes is Quality of life (EQ-5D-5L questionnaire) from baseline [Week 1 to 28]
Quality of life assesment
- Changes in physical activity (International Physical Activity Questionnaire,PAQ) [Week 1 to 28]
Physical activity assesment
- Changes in sleep (Pittsburg questionnaire) [Week 1 to 28]
Sleep assesment
- Changes in Quality of life (EORTC QLQ-LC-13 Questionnarire) [Week 1 to 28]
Quality of life assesment
- Changes in toxicity (Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events, PRO-CTAE questionnaire) [week 1 to 28]
Toxicity assesment
- Changes is Hospital Anxiety and Depresion Questionnaire (HADs) from baseline [Week 1 to 28]
Emotional status assesment
- Changes in Massachusetts General Hospital-Sexual Functioning Questionnaire (MGH-SFQ) from baseline [Week 1 to 28]
Sexuality assesment
- Changes is medication adherence (MMAS-8 questionnaire) [Week 1 to 28]
Medication adherence assesment
- Changes in belief in medication (Beliefs about Medicines Questionnaire,BMQ) [Week 1 to 28]
Belief in medication assesment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with thoracic neoplasms, histologically or cytologically confirmed.
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< 18 years.
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ECOG performance status ≤ 2.
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Patients receiving cancer treatment: chemotherapy, chemotherapy-immunotherapy, immunotherapy or biological therapy.
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Patients with internet access and intermediate level in the use of technology (Smartphone, mobile applications, wearable)
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Signed informed consent.
Exclusion Criteria:
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Patients with symptomatic brain metastases.
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Patients with neurological impairment, dementia or psychiatric disorders.
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Patients unable to follow the protocol due to psychological, social or geographic reasons.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Servicio de Oncología. Hospital Infanta Sofía | San Sebastián De Los Reyes | Madrid | Spain | 28134 |
Sponsors and Collaborators
- Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
- Hospital Infanta Sofia
- Universidad Politecnica de Madrid
- IMDEA Food
- Instituto de Investigación en Ciencias de la Alimentación (CIAL)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- mHA