Assessing the Effect of the 'Wavy' Application, on Stress and Burden of Disease in Women With INOCA

NCT06171893 | Completed

• 1 other identifier: .NL77493.091.21
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 6

Brief Summary

For women that experience angina symptoms with underlying vascular spasm as the cause, stress has an aggravating role. Coping with stress is therefore included as an important pillar in dealing with this chronic disease, see the European Association of Percutaneous Cardiovascular Interventions (EACPI) consensus document on INOCA. In practice, stress management focuses on informing and identifying the role stress plays in their lives. A potential stress management tool: "Wavy" aims to help users manage stress more consciously through biofeedback. This research focuses on the effectiveness of stress management applications. The hypothesis is that the app will help to avoid the trigger stress as much as possible and thus reduce the burden of disease.

Conditions

Stress; Ischemia; Vasospasm, Coronary; Vasomotor; Spasm; Angina, Stable; Prinzmetal Angina

Outcome Measures

Primary Outcomes (1)

• seattle angina questionnaire

  A valid, reproducible, responsive instrument for assessing disease-specific health status among patients with coronary artery disease

  10 weeks

Secondary Outcomes (5)

• VAS score on pain

  10 weeks

• Heart rate variability

  10 weeks

• Perceived stress score

  10 weeks

• SF-36

  10 weeks

• Symptom diary

  10 weeks

Study Arms (1)

Control vs intervention

EXPERIMENTAL

Each subject will take part in a four-week control period, followed by a four-week intervention period.

Behavioral: Wavy stress application

Interventions

Wavy stress application BEHAVIORAL

The intervention consists of the application named Wavy. Wavy uses artificial intelligence and the user's feedback to detect stress increasingly more efficient over time. This provides not only real-time feedback on an individual's stress level but also helps the patient to calm down using music guided relaxation. It does so with a music filter, allowing the participant to listen to music where the stress level determines the quality of the music. Thus, relaxing is rewarded by improving the experience. In this process, implicit learning is used to establish a habit of getting better at recognising increased stress levels and getting familiar with reducing stress levels more and more effectively.

Control vs intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female.
• Aged 18-70 (upper-limit, because of increased comorbidities and potential difficulties with using the technology).
• Suffering from chronic angina pectoris.
• Diagnosed with INOCA, documented within 2 years, with a coronary angiogram and an abnormal coronary function test (CFT), indicative of either epicardial or microvascular vasospasms.
• Daily usage of a smartphone with an operating system equal to or higher than Android 5.0 (Lollipop) or IOS 10.0.
• Signed written informed consent.
• Excluded criteria:
• She is not available for the assigned research period of approximately 10 weeks from May 2021 till October 2022. The application can be used during the planned holidays.
• She is unable to participate in the stress-reducing exercise, e.g., due to hearing problems.
• A language barrier is present.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• VieCuri Medical Centre: collaborator
• The Elisabeth-TweeSteden Hospital: collaborator
• Maastricht University Medical Center: collaborator
• Maasstad Hospital: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Health Holland: collaborator
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (6)

Radboud universty medical center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Maastricht UMC

Maastricht, Limburg, 6229 HX, Netherlands

Location

VieCuri

Venlo, Limburg, 5900BX, Netherlands

Location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Elisabeth-TweeSteden Hospital

Tilburg, North Brabant, 5042AD, Netherlands

Location

Maasstad Hospital

Rotterdam, South Holland, 3079 DZ, Netherlands

Location

MeSH Terms

Conditions

Ischemia; Coronary Vasospasm; Spasm; Angina, Stable; Angina Pectoris, Variant

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Angina Pectoris; Chest Pain; Pain; Angina, Unstable

Study Officials

• Suzette Elias-Smale, dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm, controlled, multicentre trial, will be conducted to validate to study objective. The study is divided into five iterative substudies of which the first four are aimed towards improving the application, based on the quantitative data from the smartwatch and the qualitative feedback of the users whilst also validating the recent version through assessing the interim study outcomes.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 15, 2023
• Study Start: August 1, 2022
• Primary Completion: December 23, 2022
• Study Completion: December 31, 2022
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6)