UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041160 |
|---|---|
| Receipt number | R000047000 |
| Scientific Title | Evaluation study of preventing exacerbations for home care patients with chronic diseases by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2023/07/24 12:19:15 |
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Basic information
Public title
Evaluation study of preventing exacerbations for home care patients with chronic diseases by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study
Acronym
Evaluation study of preventing exacerbations for home care patients by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study
Scientific Title
Evaluation study of preventing exacerbations for home care patients with chronic diseases by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study
Scientific Title:Acronym
Evaluation study of preventing exacerbations for home care patients by using dual-monitoring-based telenursing system-a prospective longitudinal mixed methods study
Region
| Japan |
Condition
Condition
COPD, IPF, Post-aspiration pneumonia, Diabetes, Amyotrophic lateral sclerosis, Congestive heat failure, Lung cancer, COVID-19
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether providing three months of dual-monitoring telenursing is useful for preventing acute exacerbations and improving participants' health outcomes by using a prospective longitudinal mixed methods study approach.
Basic objectives2
Others
Basic objectives -Others
To evaluate whether providing three months of dual-monitoring-based telenursing is useful for preventing acute exacerbations and health outcomes for people with COPD, IPF, Post- aspiration pneumonia, DM, ALS, CHF, Lung Ca and COVID-19 positive by using longitudinal mixed methods study approach.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Acute exabertions
Key secondary outcomes
Self-care, health literacy, adherance, daily living status, ALD, self-management, self-efficacy, quality of life, feeling of safety, satisfactions, depression, daily monitoring status, disease stability, prescriptions and health-care fee.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Using a telenursing system
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.COPD: Patients who receive home oxygen therapy according to stage IV chronic obstructive pulmonary disease. Includes users of non-invasive positive pressure ventilation.2.IPF: Patients with interstitial pneumonia diagnosed by Severity classification I to IV of idiopathic pulmonary fibrosis.
3.AP: A person who is diagnosed with aspiration pneumonia and starts home care after hospitalization.4.DM: Patients with diabetes stage 4 diabetic nephropathy third stage who need blood sugar/blood pressure control.5. ALS: A person who is able to visit an outpatient with a severity classification of 4 degrees or less by the Ministry of Health.6.HF: Those who is NYHA classification II-III of chronic heart failure due to angina, coronary artery disease, valvular disease, cardiomyopathy, etc.7.Lung ca: Those receiving cancer drug therapy due to lung cancer. 8.COVID-19 positive.
Target selection criteria (1) Those who regularly visit the outpatient clinic and continue to receive medical treatment.(2)Those who can obtain the consent of the attending physician to participate in this study.(3)A person who can secure a place to install a tablet terminal and a set of measuring equipment in the target person's home.(4)Those who have no hindrance to cognitive function, have alternatives to limb functions, can self-measure daily blood pressure, oxygen saturation, etc., and can answer questions, and understand terminal operations.(5)Those who can use the long-term care insurance service, social resources, etc. regardless of the usage status, even during the research cooperation period.(6)Age 65 years old or older (However, only ALS must be aged 60 years old or older).
Key exclusion criteria
Exclusion criteria will be:
1. Those who are in the end-stage status
2. Those who are in a state of serious depression
3. A person who has a decline in cognitive functions or a decline in limb function and cannot obtain assistance in operating the telenursing devices.
4.Those who need hospital treatment
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamei |
Organization
St. Luke's International University Graduate School
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-5550-2283
kamei@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kamei |
Organization
St. Luke's International University Graduate School
Division name
Graduate School of Nursing Science
Zip code
1040044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-5550-2283
Homepage URL
kamei@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Healthcare University, Tokyo Metropolitan Institute of Medical Science, Hamamatsu University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University Research Administration Office
Address
10-1 Akashi-cho, Chuo-ku, Tokyo
Tel
03-5550-2423
kenkyukikaku@luke.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047000
