Improvement of Sleep in COPD Patients Through Inhalation Management Education by Nurse.
NCT ID: NCT07311499
Last Updated: 2025-12-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-01-31
Study Completion Date
2029-03-31
Brief Summary
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This study aims to investigate whether inhalation management education provided by nurses improves sleep quality in patients with COPD. Inhalation management education includes training in inhalation techniques and guidance on how to use medications when symptoms occur.
The main research question is:
・Does inhalation management education improve sleep quality in patients with COPD?
Researchers will determine whether inhalation management education improves sleep quality compared to no education.
Participants will:
* Participate in two interviews with researchers using video conferencing tools.
* Keep a diary recording their symptoms, sleep duration, and the frequency of rescue inhaler use.
The main research question is:
・Does inhalation management education improve sleep quality in patients with COPD?
Researchers will determine whether inhalation management education improves sleep quality compared to no education.
Participants will:
* Participate in two interviews with researchers using video conferencing tools.
* Keep a diary recording their symptoms, sleep duration, and the frequency of rescue inhaler use.
Detailed Description
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●Research participants, eligibility criteria, and exclusion criteria The study will include stable COPD patients who are outpatients at Kumamoto University Hospital, Kounan Hospital, or Iwakuni City Nishiki Central Hospital, which specialize in internal and respiratory medicine. Eligible participants must meet all of the following criteria and must not meet any exclusion criteria.
【Eligibility Criteria】
1. Aged 20 years or older at the time of informed consent.
2. Prescribed inhaled medications and have used them continuously for at least one month.
3. No prior experience with inhalation therapy required.
4. No hospitalization for COPD exacerbation within one month prior to study enrollment.
5. Patients with obstructive sleep apnea (OSAS) overlap syndrome (OVS) receiving nasal continuous positive airway pressure (CPAP) therapy are eligible if their symptoms are stable, as determined by a physician after CPAP initiation.
6. Able to operate a device such as an Android tablet, iPad, or computer; if not, participation is still acceptable if a caregiver can operate the device.
7. Individuals deemed to be in a stable condition by a physician and who have obtained permission.
【exclusion criterias】
1. Presence of other respiratory diseases such as asthma or interstitial pneumonia.
2. Presence of advanced cancer, including lung cancer.
3. Restricted chest movement due to chest deformity or trauma
4. Sleep-disordered breathing with a central apnea-hypopnea index (AHI) exceeding 50%.
5. Sleep-disordered breathing with a central AHI of more than half
6. Diagnosis of dementia or other psychiatric disorders.
* Registration of study subjects The attending physician at the collaborating research institution will refer patients who meet the eligibility criteria for the study, and the principal investigator or research collaborator will obtain the patient's consent directly. The purpose and significance of the study, the methods, and ethical considerations will be explained verbally and in writing, and written consent will be obtained. After obtaining consent, a study subject identification code will be assigned, and the study subject will be registered in this study.
* Allocation method A stratified block allocation will be performed using gender (male, female) and severity classification (GOLD Grade 1, 2, 3, 4) as allocation factors. The allocation of study participants to each treatment group will be conducted by Makiko Yamamoto at the Department of Basic Nursing Science, Kumamoto University Graduate School of Nursing.
Following the pre-established random allocation table, participants will be sequentially assigned to each treatment group in the order of case registration, and a registration confirmation form will be issued, indicating the participant's registration number and treatment group. The allocation table will be retained by the allocation officer and will not be disclosed to the principal investigator or co-investigators.
●Sample size Target number of participants (Total: 34 cases) Intervention group: 17 cases Control group: 17 cases Number of participants expected to enroll(Total: 60 cases) Intervention group: 30 cases Control group: 30 cases There are no previous studies measuring the effect of inhalation management education on sleep quality. In previous studies, the average PSQI score for COPD patients was 8.3-11.5 points, and the PSQI cutoff value is 5.5 points. Assuming a change of 5.0 points in the average PSQI-J score after 3 months in the intervention group, the sample size required to maintain a two-sided test (significance level 5%) with 80% power is 17 cases per group. Considering that many participants are elderly and may have difficulty continuing to use computers or video conferencing tools, a higher dropout rate than usual is anticipated. Therefore, 30 participants per group, totaling 60 participants, will be enrolled in the study.
●Criteria for exclusion from analysis The definition of the analysis population is as follows.
-Full Analysis Set (FAS) The FAS consists of all study subjects who provided informed consent, excluding the following study subjects.
* Cases that do not meet the primary eligibility criteria (e.g., diagnosed with a disease outside the scope of the study, or found to have violated objectively determinable selection or exclusion criteria) • Cases with no post-randomization measurements -The population compliant with the study protocol (Per Protocol Set: PPS)
The PPS is defined as the FAS excluding the following subjects:
• Cases with unavailable measurements of the primary endpoint
• Cases with major protocol violations (e.g., allocation errors, failure to meet eligibility criteria, non-compliance with medication)
This study will clearly identify the breakdown of cancellations and dropouts by compiling data on the number of registered subjects who were excluded from the analysis population and the reasons for their exclusion, broken down by analysis population.
●Analysis and statistical methods for verifying evaluation items Statistical analysis will be performed using JMP Pro 18, with a significance level set at 5%.
-Analysis of primary endpoints Primary endpoint: Change in PSQI-J at 3 months before and after the educational intervention The primary endpoint will be analyzed using the FAS. The change in PSQI-J scores will be calculated for each group, and independent t-tests will be performed to compare groups at a significance level (two-sided) of 5%. A similar analysis will be conducted using PPS as the analysis population as a secondary analysis.
-Using FAS as the analysis population, the difference in the mean change in JESS, Japanese CAT, and HADS scores between groups will be analyzed using a paired t-test at a significance level of 5%. Similar analyses will also be conducted using PPS as the analysis population.
In this study, baseline data for the primary outcome measure, PSQI, were missing at study registration. If PSQI-J was measured within one month of baseline (prior to the first intervention), that data was used to impute baseline data for PSQI-J. This method of data imputation may result in the presence of data from different measurement time points at baseline.
However, since the PSQI-J reflects sleep quality over the past month and no interventions were conducted during that period, this method of data supplementation is considered appropriate. For other items, missing values will not be supplemented.
Information on patients obtained at baseline from participants who withdrew from the study or withdrew their consent will be used for analysis if consent is obtained from the participants themselves, as it constitutes valuable data on inhalation techniques, inhalation education, and methods for current COPD patients.
●Criteria for discontinuing participation in research The principal investigator or co-investigator shall terminate the study if they determine that it is impossible to continue the study for any of the following reasons.
\<Termination Criteria\>
• If a research subject withdraws from the study or revokes their consent
• If it is determined after registration that the subject no longer meets the eligibility criteria (inclusion/exclusion criteria)
* If the subject requires emergency hospitalization and treatment due to worsening of the underlying disease
* If the study cannot be continued due to worsening of complications
* If the study cannot be continued due to adverse events
* If the study is terminated
* If the physician determines that termination of the study is appropriate for other reasons
【Eligibility Criteria】
1. Aged 20 years or older at the time of informed consent.
2. Prescribed inhaled medications and have used them continuously for at least one month.
3. No prior experience with inhalation therapy required.
4. No hospitalization for COPD exacerbation within one month prior to study enrollment.
5. Patients with obstructive sleep apnea (OSAS) overlap syndrome (OVS) receiving nasal continuous positive airway pressure (CPAP) therapy are eligible if their symptoms are stable, as determined by a physician after CPAP initiation.
6. Able to operate a device such as an Android tablet, iPad, or computer; if not, participation is still acceptable if a caregiver can operate the device.
7. Individuals deemed to be in a stable condition by a physician and who have obtained permission.
【exclusion criterias】
1. Presence of other respiratory diseases such as asthma or interstitial pneumonia.
2. Presence of advanced cancer, including lung cancer.
3. Restricted chest movement due to chest deformity or trauma
4. Sleep-disordered breathing with a central apnea-hypopnea index (AHI) exceeding 50%.
5. Sleep-disordered breathing with a central AHI of more than half
6. Diagnosis of dementia or other psychiatric disorders.
* Registration of study subjects The attending physician at the collaborating research institution will refer patients who meet the eligibility criteria for the study, and the principal investigator or research collaborator will obtain the patient's consent directly. The purpose and significance of the study, the methods, and ethical considerations will be explained verbally and in writing, and written consent will be obtained. After obtaining consent, a study subject identification code will be assigned, and the study subject will be registered in this study.
* Allocation method A stratified block allocation will be performed using gender (male, female) and severity classification (GOLD Grade 1, 2, 3, 4) as allocation factors. The allocation of study participants to each treatment group will be conducted by Makiko Yamamoto at the Department of Basic Nursing Science, Kumamoto University Graduate School of Nursing.
Following the pre-established random allocation table, participants will be sequentially assigned to each treatment group in the order of case registration, and a registration confirmation form will be issued, indicating the participant's registration number and treatment group. The allocation table will be retained by the allocation officer and will not be disclosed to the principal investigator or co-investigators.
●Sample size Target number of participants (Total: 34 cases) Intervention group: 17 cases Control group: 17 cases Number of participants expected to enroll(Total: 60 cases) Intervention group: 30 cases Control group: 30 cases There are no previous studies measuring the effect of inhalation management education on sleep quality. In previous studies, the average PSQI score for COPD patients was 8.3-11.5 points, and the PSQI cutoff value is 5.5 points. Assuming a change of 5.0 points in the average PSQI-J score after 3 months in the intervention group, the sample size required to maintain a two-sided test (significance level 5%) with 80% power is 17 cases per group. Considering that many participants are elderly and may have difficulty continuing to use computers or video conferencing tools, a higher dropout rate than usual is anticipated. Therefore, 30 participants per group, totaling 60 participants, will be enrolled in the study.
●Criteria for exclusion from analysis The definition of the analysis population is as follows.
-Full Analysis Set (FAS) The FAS consists of all study subjects who provided informed consent, excluding the following study subjects.
* Cases that do not meet the primary eligibility criteria (e.g., diagnosed with a disease outside the scope of the study, or found to have violated objectively determinable selection or exclusion criteria) • Cases with no post-randomization measurements -The population compliant with the study protocol (Per Protocol Set: PPS)
The PPS is defined as the FAS excluding the following subjects:
• Cases with unavailable measurements of the primary endpoint
• Cases with major protocol violations (e.g., allocation errors, failure to meet eligibility criteria, non-compliance with medication)
This study will clearly identify the breakdown of cancellations and dropouts by compiling data on the number of registered subjects who were excluded from the analysis population and the reasons for their exclusion, broken down by analysis population.
●Analysis and statistical methods for verifying evaluation items Statistical analysis will be performed using JMP Pro 18, with a significance level set at 5%.
-Analysis of primary endpoints Primary endpoint: Change in PSQI-J at 3 months before and after the educational intervention The primary endpoint will be analyzed using the FAS. The change in PSQI-J scores will be calculated for each group, and independent t-tests will be performed to compare groups at a significance level (two-sided) of 5%. A similar analysis will be conducted using PPS as the analysis population as a secondary analysis.
-Using FAS as the analysis population, the difference in the mean change in JESS, Japanese CAT, and HADS scores between groups will be analyzed using a paired t-test at a significance level of 5%. Similar analyses will also be conducted using PPS as the analysis population.
In this study, baseline data for the primary outcome measure, PSQI, were missing at study registration. If PSQI-J was measured within one month of baseline (prior to the first intervention), that data was used to impute baseline data for PSQI-J. This method of data imputation may result in the presence of data from different measurement time points at baseline.
However, since the PSQI-J reflects sleep quality over the past month and no interventions were conducted during that period, this method of data supplementation is considered appropriate. For other items, missing values will not be supplemented.
Information on patients obtained at baseline from participants who withdrew from the study or withdrew their consent will be used for analysis if consent is obtained from the participants themselves, as it constitutes valuable data on inhalation techniques, inhalation education, and methods for current COPD patients.
●Criteria for discontinuing participation in research The principal investigator or co-investigator shall terminate the study if they determine that it is impossible to continue the study for any of the following reasons.
\<Termination Criteria\>
• If a research subject withdraws from the study or revokes their consent
• If it is determined after registration that the subject no longer meets the eligibility criteria (inclusion/exclusion criteria)
* If the subject requires emergency hospitalization and treatment due to worsening of the underlying disease
* If the study cannot be continued due to worsening of complications
* If the study cannot be continued due to adverse events
* If the study is terminated
* If the physician determines that termination of the study is appropriate for other reasons
Conditions
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Chronic Obstructive Lung Disease
Keywords
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COPD
inhalation management education
sleep quality
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Study Groups
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education intervention group
Group Type
ACTIVE_COMPARATOR
inhalation management education
Intervention Type
BEHAVIORAL
* During interviews with researchers, undergo a technical check. Then, practice inhalation techniques.
* During interviews with researchers, discuss solutions to symptoms and problems encountered in daily life.
* Participants implement the solutions decided upon during the observation period.
* During the second intervention, assess whether the solutions were effective and, if not, consider alternative solutions.
Normal care group
Provide a pamphlet tailored to the patient's inhalation device.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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inhalation management education
* During interviews with researchers, undergo a technical check. Then, practice inhalation techniques.
* During interviews with researchers, discuss solutions to symptoms and problems encountered in daily life.
* Participants implement the solutions decided upon during the observation period.
* During the second intervention, assess whether the solutions were effective and, if not, consider alternative solutions.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Individuals aged 20 years or older at the time of consent.
* Individuals who have been prescribed inhaled medications and have been using them continuously for more than one month.
* Prior experience with inhalation instruction is not required.
* Individuals who have not been hospitalized within one month prior to study participation due to exacerbation of COPD.
* Individuals with obstructive sleep apnea syndrome (OSAS) who are receiving treatment with continuous positive airway pressure (CPAP) therapy are eligible, provided that the physician determines that symptoms are stable following CPAP initiation.
* Participants must be able to operate devices such as Android, iPad, or computer. However, if a caregiver can operate the device, the participant's inability to do so is acceptable.
* Participants must be in a stable condition as determined by a physician and have obtained permission to participate.
* Individuals who have been prescribed inhaled medications and have been using them continuously for more than one month.
* Prior experience with inhalation instruction is not required.
* Individuals who have not been hospitalized within one month prior to study participation due to exacerbation of COPD.
* Individuals with obstructive sleep apnea syndrome (OSAS) who are receiving treatment with continuous positive airway pressure (CPAP) therapy are eligible, provided that the physician determines that symptoms are stable following CPAP initiation.
* Participants must be able to operate devices such as Android, iPad, or computer. However, if a caregiver can operate the device, the participant's inability to do so is acceptable.
* Participants must be in a stable condition as determined by a physician and have obtained permission to participate.
Exclusion Criteria
* Suffering from other respiratory diseases such as asthma or interstitial pneumonia
* Suffering from advanced cancer, including lung cancer
* Restricted chest movement due to chest deformity or trauma
* Suffering from diseases that cause respiratory distress, such as heart disease
* Suffering from sleep-disordered breathing with a central AHI of more than 50%
* Diagnosed with dementia or mental illness
* Suffering from advanced cancer, including lung cancer
* Restricted chest movement due to chest deformity or trauma
* Suffering from diseases that cause respiratory distress, such as heart disease
* Suffering from sleep-disordered breathing with a central AHI of more than 50%
* Diagnosed with dementia or mental illness
Minimum Eligible Age
20 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hiroshima University
OTHER
Sponsor Role
collaborator
Kumamoto University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Kumamoto University
Kumamoto, Chuo-ku, Japan
Site Status
Countries
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Japan
Central Contacts
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References
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Moriyama M, Takeshita Y, Haruta Y, Hattori N, Ezenwaka CE. Effects of a 6-month nurse-led self-management program on comprehensive pulmonary rehabilitation for patients with COPD receiving home oxygen therapy. Rehabil Nurs. 2015 Jan-Feb;40(1):40-51. doi: 10.1002/rnj.119. Epub 2013 Aug 6.
Reference Type
RESULT
Al-Kalaldeh M, El-Rahman MA, El-Ata A. Effectiveness of Nurse-Driven Inhaler Education on Inhaler Proficiency and Compliance Among Obstructive Lung Disease Patients: A Quasi-Experimental Study. Can J Nurs Res. 2016 Jun;48(2):48-55. doi: 10.1177/0844562116676119.
Reference Type
RESULT
Sauriasari R, Madani RA, Rozaliyani A, Sudiana D. The effect of repeated education using live demonstrations and videos of how to use inhalation drugs on quality of life for COPD patients. Heliyon. 2021 Aug 24;7(9):e07870. doi: 10.1016/j.heliyon.2021.e07870. eCollection 2021 Sep.
Reference Type
RESULT
Muller T, Muller A, Hubel C, Knipel V, Windisch W, Cornelissen CG, Dreher M. Optimizing inhalation technique using web-based videos in obstructive lung diseases. Respir Med. 2017 Aug;129:140-144. doi: 10.1016/j.rmed.2017.06.009. Epub 2017 Jun 17.
Reference Type
RESULT
Ngo CQ, Phan DM, Vu GV, Dao PN, Phan PT, Chu HT, Nguyen LH, Vu GT, Ha GH, Tran TH, Tran BX, Latkin CA, Ho CSH, Ho RCM. Inhaler Technique and Adherence to Inhaled Medications among Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Vietnam. Int J Environ Res Public Health. 2019 Jan 10;16(2):185. doi: 10.3390/ijerph16020185.
Reference Type
RESULT
Ahn JH, Chung JH, Shin KC, Jin HJ, Jang JG, Lee MS, Lee KH. The effects of repeated inhaler device handling education in COPD patients: a prospective cohort study. Sci Rep. 2020 Nov 12;10(1):19676. doi: 10.1038/s41598-020-76961-y.
Reference Type
RESULT
Lindh A, Theander K, Arne M, Lisspers K, Lundh L, Sandelowsky H, Stallberg B, Westerdahl E, Zakrisson AB. One additional educational session in inhaler use to patients with COPD in primary health care - A controlled clinical trial. Patient Educ Couns. 2022 Sep;105(9):2969-2975. doi: 10.1016/j.pec.2022.05.013. Epub 2022 May 26.
Reference Type
RESULT
Bouloukaki I, Tzanakis N, Mermigkis C, Giannadaki K, Moniaki V, Mauroudi E, Michelakis S, Schiza SE. Tiotropium Respimat Soft Mist Inhaler versus HandiHaler to improve sleeping oxygen saturation and sleep quality in COPD. Sleep Breath. 2016 May;20(2):605-12. doi: 10.1007/s11325-015-1259-y. Epub 2015 Sep 25.
Reference Type
RESULT
Krachman SL, Vega ME, Yu D, Demidovich J, Patel H, Jaffe F, Soler X, Shariff T, D'Alonzo GE, Chatila W, Weaver S, Daraz Y, Cohen S, Criner GJ. Effect of Triple Therapy with Budesonide-Formoterol-Tiotropium Versus Placebo-Tiotropium on Sleep Quality in Patients with Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2021 Apr 27;8(2):219-229. doi: 10.15326/jcopdf.2020.0178.
Reference Type
RESULT
Sulaiman I, Seheult J, Sadasivuni N, MacHale E, Killane I, Giannoutsos S, Cushen B, Mokoka MC, Bhreathnach AS, Boland F, Reilly RB, Costello RW. The Impact of Common Inhaler Errors on Drug Delivery: Investigating Critical Errors with a Dry Powder Inhaler. J Aerosol Med Pulm Drug Deliv. 2017 Aug;30(4):247-255. doi: 10.1089/jamp.2016.1334. Epub 2017 Mar 9.
Reference Type
RESULT
Lee SH, Kim KU, Lee H, Park HK, Kim YS, Lee MK. Sleep disturbance in patients with mild-moderate chronic obstructive pulmonary disease. Clin Respir J. 2019 Dec;13(12):751-757. doi: 10.1111/crj.13085. Epub 2019 Aug 30.
Reference Type
RESULT
Czerwaty K, Dzaman K, Sobczyk KM, Sikorska KI. The Overlap Syndrome of Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease: A Systematic Review. Biomedicines. 2022 Dec 21;11(1):16. doi: 10.3390/biomedicines11010016.
Reference Type
RESULT
Azuma M, Chin K, Yoshimura C, Takegami M, Takahashi K, Sumi K, Nakamura T, Nakayama-Ashida Y, Minami I, Horita S, Oka Y, Oga T, Wakamura T, Fukuhara S, Mishima M, Kadotani H. Associations among chronic obstructive pulmonary disease and sleep-disordered breathing in an urban male working population in Japan. Respiration. 2014;88(3):234-43. doi: 10.1159/000366064. Epub 2014 Aug 22.
Reference Type
RESULT
Climaco DCS, Lustosa TC, Silva MVFP, Lins-Filho OL, Rodrigues VK, Oliveira-Neto LAP, Feitosa ADM, Queiroga FJP Jr, Cabral MM, Pedrosa RP. Sleep quality in COPD patients: correlation with disease severity and health status. J Bras Pneumol. 2022 Apr 29;48(3):e20210340. doi: 10.36416/1806-3756/e20210340. eCollection 2022.
Reference Type
RESULT
Lin L, Song Q, Duan J, Liu C, Cheng W, Zhou A, Peng Y, Zhou Z, Zeng Y, Chen Y, Cai S, Chen P. The impact of impaired sleep quality on symptom change and future exacerbation of chronic obstructive pulmonary disease. Respir Res. 2023 Mar 30;24(1):98. doi: 10.1186/s12931-023-02405-6.
Reference Type
RESULT
Shorofsky M, Bourbeau J, Kimoff J, Jen R, Malhotra A, Ayas N, Tan WC, Aaron SD, Sin DD, Road J, Chapman KR, O'Donnell DE, Maltais F, Hernandez P, Walker BL, Marciniuk D, Kaminska M; Canadian Respiratory Research Network; CanCOLD Collaborative Research group. Impaired Sleep Quality in COPD Is Associated With Exacerbations: The CanCOLD Cohort Study. Chest. 2019 Nov;156(5):852-863. doi: 10.1016/j.chest.2019.04.132. Epub 2019 May 28.
Reference Type
RESULT
Kwon JS, Wolfe LF, Lu BS, Kalhan R. Hyperinflation is associated with lower sleep efficiency in COPD with co-existent obstructive sleep apnea. COPD. 2009 Dec;6(6):441-5. doi: 10.3109/15412550903433000.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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24K14058
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
202430036
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Diversity initiatives
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
No. 2591
Identifier Type: -
Identifier Source: org_study_id