Clinical trial NCT05380726: Effectiveness of an E-health Intervention in Patients With Obstructive Sleep Apnoea
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnoea
eHealth tools
patient education
blood pressure
therapeutic exercise
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
Collaborators: name: Institut de Recerca Biomèdica de Lleida
name: Horizon 2020 - European Commission
First posted: 2022-05-19
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: We will carry out a mixed-method exploratory sequential investigation with a realistic evaluation approach. The use of this mixed methodology allows us to use the strengths of the qualitative and quantitative phases while reducing their weaknesses. Specifically, the sequential exploratory design includes an initial qualitative phase followed by a quantitative phase, with the aim of developing an educational tool. In this project it is proposed that both phases should have the same relevance (QUAL-QUAN) for the development of the educational tool and the development of the study should be carried out in three stages. During all phases of the project, the realistic evaluation approach will be taken into account, especially after the intervention, carrying out different semi-structured interviews and focus groups to redefine the cycle and optimize future research.
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnoea is a highly burdensome condition that not only impairs function but also confers a risk of cardiovascular disease. This is particularly evident among those who are poorly compliant with continuous positive airway pressure ventilation therapy. In the management of a chronic and frequent pathology such as OSA, it is necessary to have personalized programs that implement new technology-based tools to improve the comprehensive management of the patient in order to reduce the morbidity associated with this disease.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure
timeFrame: Pre-post (after 3 months of intervention)
Secondary outcomes:
measure: Polysgraphy
timeFrame: Pre-post (after 3 months of intervention)
measure: The Pittsburgh Sleep Quality Inventory (PSQI)
timeFrame: Pre-post (after 3 months of intervention)
measure: Daytime sleepiness assessment
timeFrame: Pre-post (after 3 months of intervention)
measure: Six-minute walk test (6MWT)
timeFrame: Pre-post (after 3 months of intervention)
measure: Empowerment and motivation for change
timeFrame: Pre-post (after 3 months of intervention)
measure: Health-related quality of life
timeFrame: Pre-post (after 3 months of intervention)
measure: Anthropometry measurement 1
timeFrame: Pre-post (after 3 months of intervention)
measure: Anthropometry measurements 2
timeFrame: Pre-post (after 3 months of intervention)
measure: Adherence to the program/treatment
timeFrame: Post intervention (after 3 months)
measure: Cost-benefit
timeFrame: Post intervention (after 3 months)
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Biomedical Research Institure of Lleida
Study officials:
affiliation: Biomedical Research Institute of Lleida
name: Fran Valenzuela-Pascual, PhD
role: PRINCIPAL_INVESTIGATOR
References: