Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue

NCT05631171 | Completed

• 1 other identifier: FAT-22-002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

Adhera® Fatigue Digital Program (or AFDP) is a digital health program based on behavioral and emotional change techniques that provides personalized physical and emotional self-management support for patients with long COVID-related fatigue. The digital health solution is designed to be used for 3 months, and includes a mobile application and a smartwatch. This is a clinical study, with 30 participants in the experimental intervention group and 30 in the control group, that will be carried out at the Jordi Gol Primary Care Research Institute (IDIAPJGol) - Institut Català de la Salut and Distrito sanitario Aljarafe-Sevilla Norte (DASN) - Servicio Andaluz de Salud, in Spain. The investigators will focus on evaluating the feasibility of the program in supporting fatigue and also physical and emotional self-management and, consequently, in improving the patients' well-being and quality of life.

Conditions

Post-Acute COVID19 Syndrome; Fatigue

Keywords

Long COVID; digital health; fatigue; emotional health; behavioral intervention; mental wellbeing

Outcome Measures

Primary Outcomes (9)

• Health-related quality of life

  measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.

  baseline

• Health-related quality of life

  measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.

  month 1

• Health-related quality of life

  measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.

  month 3

• Fatigue

  Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.

  baseline

• Fatigue

  Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.

  month 1

• Fatigue

  Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.

  month 3

• Emotional wellness

  measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.

  baseline

• Emotional wellness

  measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.

  month 1

• Emotional wellness

  measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.

  month 3

Secondary Outcomes (13)

• Behavioral outcome: Usability

  month 1

• Behavioral outcome: Usability

  month 3

• Fatigue-related symptomatology

  month 1

• Fatigue-related symptomatology

  month 3

• Mood

  baseline

Study Arms (2)

Solution group

EXPERIMENTAL

The study sample will consist of 60 patients, 30 of whom will be randomly assigned to a control group and 30 to the experimental group. Validated questionnaires will be administered to the participants of both groups, at the beginning of the study, at 1 month and 3 months by Microsoft Forms. In addition, the experimental group will be given a smartwatch to each person which will collect real-time data on activity, training and sleep in a completely anonymous way. Also, through a mobile application, the patient of the experimental group will answer questionnaires about health status perception. The application has also been trained to provide educational content and motivational messages to support the patient's self-management. The data provided by patients in both groups of the study will be coded, in order to maintain the confidentiality of the individual.

Behavioral: Adhera® Fatigue Digital Program

Control group

NO INTERVENTION

The study sample will consist of 60 patients, 30 of whom will be randomly assigned to a control group and 30 to the experimental group. Validated questionnaires will be administered to the participants of both groups, at the beginning of the study, at 1 month and 3 months by Microsoft Forms.

Interventions

Adhera® Fatigue Digital Program BEHAVIORAL

Adhera® Fatigue Digital Program, that includes an application and a smartwatch, is a digital health solution based on emotional and behavioral change techniques. Patient adaptative self-management content (e.g. psycho-educational content, activities for mental wellbeing, personalized motivational messages), and the personalization is based on Adhera® Health Recommender System. Wearable devices and the mobile app will be used to collect real-time data for 3 months to detect biometric and psychometric (patient-reported outcomes) information.

Solution group

Eligibility Criteria

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

You may qualify if:

• Individuals over 18 years of age.
• With long COVID, according to the World Health Organization (WHO) consensus definition
• Having a history of fatigue symptoms
• Obtain a score between 4 and 10 on the question "By how much do you rate your fatigue level from 0 to 10 in the last 7 days?", where 0 is no fatigue and 10 is the worst fatigue imaginable
• Have an Android or iOS smartphone compatible with the intervention program.
• Agree to participate in the study and sign the informed consent form
• Willingness and availability to comply with all study guidelines and procedures

You may not qualify if:

• Hospital admission during the period of study participation.
• Participation in another study with pharmacological treatment
• Patients who are not technologically literate or unable to use the mobile application.
• Known severe psychiatric illness or presence of relevant cognitive impairment, at the discretion of the recruiting physician
• With mobility restrictions that limit the patient's ability to perform mild physical activity
• Being pregnant
• Patients who do not understand or speak Catalan or Spanish.

Sponsors & Collaborators

• Adhera Health, Inc.: lead
• Institut Català de la Salut: collaborator
• Andaluz Health Service: collaborator

Study Sites (2)

Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut

Sant Fruitós de Bages, Barcelona, 08272, Spain

Location

Servicio Andaluz de Salud - Distrito Sanitario Aljarafe-Sevilla Norte

Seville, 41008, Spain

Location

Related Links

• Withings Scanwatch wearable

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue; Psychological Well-Being

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Experimental intervention arm in parallel to control arm

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 30, 2022
• Study Start: December 13, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)