Effectiveness of an E-health Intervention in Patients With Obstructive Sleep Apnoea
Effectiveness of an E-health Intervention on Blood Pressure, Sleep Quality and Physical Activity in Patients With Obstructive Sleep Apnoea: A Sequential Exploratory Mixed-method Research Protocol With a Realist Evaluation Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives: The purpose of this study is to evaluate the effectiveness of eHealth tools in managing obstructive sleep apnoea pathophysiological consequences and how they impact the quality of life after 3 months of intervention in adults.Qual: To identify OSA patients' beliefs concerning their condition and its treatment. Connection: To construct the information resources that the mobile application will offer using the QUAL results. Quan: Objective sleep parameters, Subjective sleep quality , Daytime sleepiness Physical activity habits, Quality of life related to health, Self-efficacy and empowerment, Anthropometry, Adherence to the program/treatment, Cost / benefit.
Design: Mixed-method sequential exploratory design with realist evaluation approach.
Population and sample: Patients referred to the sleep unit of the Arnau de Vilanova - Santa María Hospital for a suspected diagnosis of obstructive sleep apnoea. For the qualitative phase, the subjects will be contacted and invited to participate in a semi-structured personal interview related to the gaps and knowledge needs that these types of patients have about the pathology itself and its management. The quantitative phase will be a randomized controlled trial. Subjects will be randomly assigned using a simple random technique. The experimental group will receive an eHealth intervention through an electronic wristband device and access to the eHealth tool (phone application) that will offer specific recommendations on health, physical activity and hygienic-dietary advice. All these recommendations will be based on the information obtained in the qualitative phase and the parameters mesured by the electronic wristband device in real time. Those in the control group will receive the same electronic wristband device and the same access to the ehealth tool, but the information received will be based on the general hygienic-dietary measures that the sleep unit provides to all patients.
This research belongs to Moore4Medical project. It has received funding within the Electronic Components and Systems for European Leadership Joint Undertaking (ECSEL JU) in collaboration with the European Union's H2020 Framework Programme (H2020/2014-2020) and National Authorities, under grant agreement H2020-ECSEL-2019-IA-876190.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Oriol o Martínez-Navarro
- Phone Number: +34 619562618
- Email: omartinez@irblleida.cat
Study Contact Backup
- Name: Fran Valenzuela-Pascual
- Email: fran.valenzuela@udl.cat
Study Locations
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Lleida, Spain, 25198
- Recruiting
- Biomedical Research Institure of Lleida
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Contact:
- Fran Valenzuela-Pascual
- Email: fran.valenzuela@udl.cat
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Contact:
- Oriol Martínez-Navarro
- Phone Number: +34 619562618
- Email: omartinez@irblleida.cat
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Principal Investigator:
- Fran Valenzuela-Pascual, PhD
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Sub-Investigator:
- Manuel Sánchez de la Torre, PhD
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Sub-Investigator:
- Esther Rubinat Arnaldo, PhD
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Sub-Investigator:
- Joan Blanco Blanco, PhD
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Sub-Investigator:
- María Masbernat-Almenara, PhD
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Sub-Investigator:
- Francesc Rubí Carnacea, PhD
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Sub-Investigator:
- Blanca Manuel Martí
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Sub-Investigator:
- Rabee Adel
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Sub-Investigator:
- Xisco Verdejo Amengual
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Sub-Investigator:
- Oriol Martínez-Navarro
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Sub-Investigator:
- Ferran Barbé Illa, PhD
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Sub-Investigator:
- Gerard Torres Cortada, PhD
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Sub-Investigator:
- Jordi de Batlle Garcia, PhD
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Sub-Investigator:
- Jessica Gonzalez Gutierrez
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Moderate OSA (apnoea-hypoapnoea index (AHI)) of 15-30
- Hypertension diagnosed by 24h-ABPM
- Men and women aged ≥ 18 years
- Spanish and/or Catalan can be read, written, and spoken
- Currently residing in Lleida (Spain)
- Own or have access to mobile phone (Android and IOS)
Exclusion Criteria:
- Previous diagnosis of OSA / use of CPAP
- Pregnancy
- Body mass index (BMI) below 17
- Subjects undergoing bariatric intervention or on the waiting list for it
- Not being able to fill out questionnaires
- Incapacity to handle technology
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
A pilot study will be conducted for 2 months with a sample of 10 participants, in order to gather initial data to test the algorithm from the eHealth tool. During the QUAN phase the algorithm will provide individualized feedback and responses to the patients based on their different variables analyzed in real-time by the wrist receiver device: cardiovascular parameters, sleep quality and structure of sleep, physical activity, oxygen saturation. The eHealth tool will contain all the educational materials developed by the researchers of the study. Depending on the information received from the electronic wrist device the eHealth tool will make recommendations of educational topics as hygienic-dietary measures, sleep related habits, or physical activity. The information provided in this regard will be dependent upon the subjects' knowledge gaps/beliefs identified in the QUAL phase and the parameters measures by the electronic wrist device in each subject. |
The intervention received will be a specific patient education for each subject depending on the parameters assessed by the electronic wrist device in real-time.
The recommendation are related to different educational topics as hygienic-dietary measures and sleep related habits, or physical activity.
Other Names:
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Active Comparator: Control group
In the control group, the participants will be provided with the same electronic wrist device and access to the eHeatlh tool as the experimental group.
However, the electronic wrist device will not provide feedback based on the parameters of each individual.
The information provided by the eHealth tool will be general information from the sleep unit of the Arnau de Vilanova - Santa María Hospital instead of the materials developed from the QUAL phase.
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The intervention received will be a specific patient education for each subject depending on the parameters assessed by the electronic wrist device in real-time.
The recommendation are related to different educational topics as hygienic-dietary measures and sleep related habits, or physical activity.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood pressure
Time Frame: Pre-post (after 3 months of intervention)
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Blood pressure: Blood pressure changes after 3 months of intervention, measured with a holter blood pressure recorder (Spacelabs 90217A, Hertford: UK).
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Pre-post (after 3 months of intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Daytime sleepiness assessment
Time Frame: Pre-post (after 3 months of intervention)
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Subjective sleepiness will be assessed using the "Epworth Sleepiness Scale (ESS)" validated in Spanish.
This is a questionnaire that contains eight items that indicate the probability of falling asleep during activities of daily living, ranging from 0 (never) to 3 (high probability).
Normal values will be established between 2 and 10, with values greater than 10 indicating daytime sleepiness
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Pre-post (after 3 months of intervention)
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Empowerment and motivation for change
Time Frame: Pre-post (after 3 months of intervention)
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The Spanish version of the Health Empowerment Scale will be used to measure empowerment, while motivation will be measured using the Self-Efficacy Scale for Physical Activity
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Pre-post (after 3 months of intervention)
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Health-related quality of life
Time Frame: Pre-post (after 3 months of intervention)
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This will be assessed using the EuroQol-5D (EQ-5D) questionnaire in its valid Spanish version
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Pre-post (after 3 months of intervention)
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Anthropometry measurement 1
Time Frame: Pre-post (after 3 months of intervention)
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Body mass index (BMI) (kg / m 2).
In order to calculate BMI, Weight (kg) and height (m) will be measured using a scale and a standard stadiometer.
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Pre-post (after 3 months of intervention)
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Anthropometry measurements 2
Time Frame: Pre-post (after 3 months of intervention)
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Waist-to-hip ratio.
The waist, and hip circumferences, measured in triplicate and averaged, will be taken into consideration.
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Pre-post (after 3 months of intervention)
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Adherence to the program/treatment
Time Frame: Post intervention (after 3 months)
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Scale of adherence and number of entries to the telephone application.
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Post intervention (after 3 months)
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Cost-benefit
Time Frame: Post intervention (after 3 months)
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Comparison through the final costs of the current project and the studied costs of conservative treatment according to the research by Tarraubella et al. (2018)
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Post intervention (after 3 months)
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Polysgraphy
Time Frame: Pre-post (after 3 months of intervention)
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Twe will use respiratory polygraphy (Embletta, ResMed, Bella Vista, NSW, Australia) to assess the AHI, oxygen desaturation index (ODI, >4%), minimum and mean oxygen saturation (SaO2), the average duration of events and percentage of time with SaO2 <90%.
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Pre-post (after 3 months of intervention)
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The Pittsburgh Sleep Quality Inventory (PSQI)
Time Frame: Pre-post (after 3 months of intervention)
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) is a 19-item list of items used to measure sleep quality and disturbances over the past month.
As part of the PSQI, various sleep characteristics are measured, including sleep latency (i.e., the amount of time taken to fall asleep).
On a scale of 0 to 3, each item is scored (0 = not during the past month; 1 = less than once a week; 2 = once or twice a week; and 3 = three or more times a week) (49).
These scores are summed to generate an overall score.
The higher the scores, the lower the quality of sleep.
A score of more than five indicates poor sleep quality.
With an alpha value of 0.83, the PSQI has demonstrated reliability in its internal consistency
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Pre-post (after 3 months of intervention)
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Six-minute walk test (6MWT)
Time Frame: Pre-post (after 3 months of intervention)
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The 6MWT test evaluates the respiratory, cardiovascular, metabolic, musculoskeletal, and sensorineural responses to exercise.
It is considered a useful tool for assessing the functional capacity of patients with chronic respiratory and/or cardiovascular diseases and is used to assess the submaximal level of functional performance at a similar level required for daily physical activities (55).
6MWT measures the maximum distance an individual is able to walk as fast as possible (not run) using their usual walking aids if any, and take their regular medications before the test, in 6 minutes.
The patients can rest is allowed as required but the time is not stopped.
The 6MWT is normally carried out in a corridor of 30 meters in length, on a hard and flat surface, and preferably indoors
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Pre-post (after 3 months of intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fran Valenzuela-Pascual, PhD, Biomedical Research Institute of Lleida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOORE4MEDICAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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