UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015843 |
|---|---|
| Receipt number | R000018437 |
| Scientific Title | Effects of self-care support system using a tablet computer on adherence to self-monitoring in patients with chronic heart failure: A pilot study |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2025/01/19 12:45:58 |
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Basic information
Public title
Effects of self-care support system using a tablet computer on adherence to self-monitoring in patients with chronic heart failure: A pilot study
Acronym
Effects of self-care support system using a tablet computer on adherence to self-monitoring in patients with chronic heart failure: A pilot study
Scientific Title
Effects of self-care support system using a tablet computer on adherence to self-monitoring in patients with chronic heart failure: A pilot study
Scientific Title:Acronym
Effects of self-care support system using a tablet computer on adherence to self-monitoring in patients with chronic heart failure: A pilot study
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate the effects of self-care support system using a tablet computer on adherence to self-monitoring in patients with chronic heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence to self-monitoring
Key secondary outcomes
1. Ability of self-care behavior
2. Knowledge about heart failure
3. Self-efficacy
4. Quality of life
5. Physical acitivity
6. Salt intake
7. Unplanned visit or telephone consultation to the hospital regarding heart failure care
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Self-care support using a tablet computer
Interventions/Control_2
Usual care using a diary for patients with chronic heart failure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic heart failure who have a history of hospital admission due to acute exacerbation of heart failure
Key exclusion criteria
Patients who cannot use a tablet computer due to visual impairment, orthopedic disease, or neuromuscular disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tsutsui |
Organization
Hokkaido University
Division name
Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo 060-8638, Japan
TEL
011-706-6973
htsutsui@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Hokkaido University Hospital
Division name
Clinical Research and Medical Innovation Center
Zip code
060-8648
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo 060-8648, Japan
TEL
011-706-6001
Homepage URL
t-yokota@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hokkaido University Hospital
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院、小樽協会病院、市立札幌病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
https://doi.org/10.1093/ehjdh/ztad032
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1093/ehjdh/ztad032
Number of participants that the trial has enrolled
24
Results
We enrolled 24 outpatients with chronic heart failure (HF) who had a history of HF hospitalization. During the 2-month study period, the intervention group showed excellent adherence to the self-monitoring of each vital sign. At 2 months, the intervention group's self-care behavior score (evaluated by the European Heart Failure Self-Care Behaviour Scale) was significantly improved compared to the control group.
Results date posted
| 2023 | Year | 05 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 05 | Month | 10 | Day |
Baseline Characteristics
The median age (interquartile range; IQR) of the total chronic HF cohort was 60 (50-67) years; 18 (75%) of the patients were men, and six (25%) were women. Twenty-five percent of the patients were living alone. Of the total cohort, 58% had daily habits of self-monitoring before being enrolled in the study, including the measurement of blood pressure using a diary; 38% had a tablet PC or a smartphone. Before their enrollment in the study, 46% of the patients had been hospitalized for worsening HF within the prior 3 months.The primary cause of HF was ischemic heart disease (29% of the patients); dilated cardiomyopathy was the primary cause in 21%, and in the remaining 50% of the patients the causes were hypertrophic cardiomyopathy, cardiac sarcoidosis, tachycardia-induced cardiomyopathy, hypertensive heart disease, and valvular heart disease. In addition, most of the patients had a reduced left ventricular ejection fraction (median [IQR]: 32 [24-46] %).
Participant flow
We recruited patients with chronic HF who were followed at the outpatient ward of each participating hospital. Written informed consent was obtained from each patient before his or her participation in the study. After we obtained a participant's written informed consent, participants were randomly assigned in a 1:1 fashion to either the self-care support mobile app intervention group or the control (i.e., usual-care) group. The patients were followed by cardiologists at the outpatient ward of each hospital for 2 months. During the study period, two visits (at 1 month and at 2 months) were the minimum scheduled outpatient visits after the initiation of the study.
Adverse events
There were no adverse events in either of participants during study period.
Outcome measures
The primary compliance outcome measure was adherence to the self-monitoring of four core vital signs (blood pressure, body weight, body temperature, and oxygen saturation) for 2 months. The adherence to self-monitoring was evaluated by the patient's records in the app (intervention group) or in the HF diary (control group). The study's primary efficacy outcome measure was self-care behavior evaluated by the European Heart Failure Self-Care Behaviour Scale at 2 months. Other measures included the HF Knowledge Scale, the General Self-Efficacy Scale, and the SF-8 at 2 months.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018437
