| Condition or disease | Intervention/treatment |
|---|---|
| Chronic Obstructive Pulmonary Disease | Diagnostic Test: Structured self-monitoring during an altitude ascent and stay at high altitude |
This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel. After baseline evaluation at 760 m, patients will travel by bus within 3-5 h to the Tuja Ashu high altitude clinic at 3'100 m and stay there for 2 days. During this period, participants will perform SSM. They are instructed to report to study personnel if they fulfill predefined criteria for impeding altitude-related illness.
A planned interim analysis will be performed after the first year of the study or after completion of study by 80 participants, whichever comes first to allow any necessary adaptations of the sample size or terminate the study early for futility or high accuracy of the index test.
| Study Type : | Observational |
| Estimated Enrollment : | 200 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Self-Monitoring for Early Signs of Altitude Illness in Patients With Chronic Obstructive Pulmonary Disease. A Diagnostic Test Accuracy Study. |
| Actual Study Start Date : | May 20, 2019 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | September 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
| COPD patients |
Diagnostic Test: Structured self-monitoring during an altitude ascent and stay at high altitude
Structured self-monitoring by a symptom checklist in combination with a pulse oximeter worn at the wrist in lowlanders with COPD ascending from low altitude (760m) to high altitude (3100m).
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Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the the curve. The diagnostic performance will be compared statistically using c-statistics against the reference test. Reference test will be the occurence of altitude-related illness defined as the following:
Incidence of ARI during the stay at 3100 m.
ARI is defined as the following:
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion criteria
Exclusion criteria
| Contact: Konrad E Bloch, MD | +41442553828 | konrad.bloch@usz.ch | |
| Contact: Michael Furian, PhD | +41442553828 | michael.furian@usz.ch |
| Kyrgyzstan | |
| National Center of Cardiology and Internal Medicine | Recruiting |
| Bishkek, Kyrgyzstan | |
| Contact: Talant M Sooronbaev, MD +996 312 625679 Sooronbaev@yahoo.com | |
| Study Chair: | Konrad E Bloch, MD | University of Zurich | |
| Study Director: | Talant M Sooronbaev, MD | National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 16, 2019 | ||||||||
| First Posted Date | May 21, 2019 | ||||||||
| Last Update Posted Date | May 13, 2021 | ||||||||
| Actual Study Start Date | May 20, 2019 | ||||||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Diagnostic accurarcy measures of structured self-monitoring [ Time Frame: Day 1 to 3 at 3100m ] Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the the curve. The diagnostic performance will be compared statistically using c-statistics against the reference test. Reference test will be the occurence of altitude-related illness defined as the following:
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Early Signs of Altitude Illness in Patients With COPD | ||||||||
| Official Title | Self-Monitoring for Early Signs of Altitude Illness in Patients With Chronic Obstructive Pulmonary Disease. A Diagnostic Test Accuracy Study. | ||||||||
| Brief Summary | This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel. | ||||||||
| Detailed Description |
This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel. After baseline evaluation at 760 m, patients will travel by bus within 3-5 h to the Tuja Ashu high altitude clinic at 3'100 m and stay there for 2 days. During this period, participants will perform SSM. They are instructed to report to study personnel if they fulfill predefined criteria for impeding altitude-related illness. A planned interim analysis will be performed after the first year of the study or after completion of study by 80 participants, whichever comes first to allow any necessary adaptations of the sample size or terminate the study early for futility or high accuracy of the index test. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with COPD, FEV1 40-80% predicted living at low altitude. | ||||||||
| Condition | Chronic Obstructive Pulmonary Disease | ||||||||
| Intervention | Diagnostic Test: Structured self-monitoring during an altitude ascent and stay at high altitude
Structured self-monitoring by a symptom checklist in combination with a pulse oximeter worn at the wrist in lowlanders with COPD ascending from low altitude (760m) to high altitude (3100m).
|
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| Study Groups/Cohorts | COPD patients
Intervention: Diagnostic Test: Structured self-monitoring during an altitude ascent and stay at high altitude
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 2021 | ||||||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion criteria
Exclusion criteria
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| Sex/Gender |
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| Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Kyrgyzstan | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03957759 | ||||||||
| Other Study ID Numbers | 01-8/464-14 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | University of Zurich | ||||||||
| Study Sponsor | University of Zurich | ||||||||
| Collaborators | National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov | ||||||||
| Investigators |
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| PRS Account | University of Zurich | ||||||||
| Verification Date | May 2021 | ||||||||