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The goal of this clinical trial is to evaluate whether a 12-week tele-rehabilitation programme with monitoring via a mobile app produces medium-term improvements in self-management, fatigue and quality of life in patients affected by persistent COVID.
The main questions it aims to answer are:
Researchers will compare an experimental breath program to a control standard care group to see if multimodal program works to treat post-exertion malaise.
Participants will:
Follow-up 12 weeks online sessions:
1 weekly synchronous online session + 1 scheduled asynchronous session + educational resources
Daily use of the app: daily log, education and questions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation program | Experimental | The interventions include:
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| Control | Active Comparator | Usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education for self-management | Other | Education program performed online including information, recommendations and guidance for promoting self-management |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient activation measure 13 | Individual's knowledge, skills and confidence to managing one's own health. is a non-disease-specific tool and can be used across different patient populations. The PAM-13 consists of 13 items on a 4-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Item scores are summed up to a raw sum score resulting in theoretical values between 13 and 52, which are then transformed to a standardized metric ranging from 0 to 100. Higher scores indicate a greater patient activation. PAM-13 scores can then be categorized into four stages of activation, corresponding to the difficulty of the PAM-13 items: level 1 (patients believe active role is important; items 1-2), level 2 (patients have confidence and knowledge to take action; items 3-8), level 3 (taking action; items 9-11) and level 4 (staying on course under stress; items 12-13). | From enrollment to end of treatment and 3 months follow-up |
| self-care self-efficacy scale | Measure for self-care self-efficacy for chronic illness. This 10-item instrument measures self-efficacy related to self-care maintenance, monitoring, and management in patients with chronic illness. Each item is rated on a '1-5' rating scale, with a higher score representing a higher level of self-efficacy. Scale scores are standardized mathematically to range from 0-100. | From enrollment to end of treatment and 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life EuroQol-5D | Quality of life related to dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is described by three possible levels of problems (no, mild to moderate and severe). Hence, this descriptive system contains three or 243 combinations, or health states. For each of these combinations, one can assign healthstate utility indices (or ''preference weights'') which are based on different value sets. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aitor Martin Pintado Zugasti | Contact | +34 913724700 | martinpintado@ceu.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEU San Pablo University | Madrid | Madrid | 28003 | Spain |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000086382 | COVID-19 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D000073278 | Self-Management |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D012046 | Rehabilitation |
| D006296 | Health Services |
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Single-blind, randomized controlled trial
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| Personalised exercise program | Other | Individualized exercise that includes progressive load adapted to each patient. It includes making flexible adjustments to their exercise (up or down as needed) to help them gradually improve their physical abilities while staying within their energy limits |
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| Usual Care | Other | Usual care these patients may receive out from the clinical trial. |
|
| From enrollment to end of treatment and 3 months follow-up |
| Fatigue Severity Scale (FSS) | Severity of fatigue and its effect on a person's activities and lifestyle. The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity. | From enrollment to end of treatment and 3 months follow-up |
| DePaul Symptom Questionnaire-Short Form (DSQ-SF) | The DSQ-SF allows investigators to use a small number of items (n = 14) to determine whether patients meet ME/CFS case definitions. Similar to the DSQ, the DSQ-SF uses the mean of the frequency and severity scores for each symptom rated over the past 6 months and linearly transforming it into a 100-point scale | From enrollment to end of treatment and 3 months follow-up |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D005159 |
| Health Care Facilities Workforce and Services |