UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061248 |
|---|---|
| Receipt number | R000069749 |
| Scientific Title | The Impact of Promoting Symptom Perception with electronic Patient-Reported outcome on Clinical Outcomes in Patients with Heart Failure.: Multicenter, randomized controlled trial. |
| Date of disclosure of the study information | 2026/04/14 |
| Last modified on | 2026/04/14 09:15:38 |
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Basic information
Public title
The Impact of Promoting Symptom Perception with electronic Patient-Reported outcome on Clinical Outcomes in Patients with Heart Failure.: Multicenter, randomized controlled trial.
Acronym
SPEC-HF Trial
Scientific Title
The Impact of Promoting Symptom Perception with electronic Patient-Reported outcome on Clinical Outcomes in Patients with Heart Failure.: Multicenter, randomized controlled trial.
Scientific Title:Acronym
SPEC-HF Trial
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will conduct a randomized controlled trial to evaluate the clinical utility of promoting symptom awareness through time-course screening of heart failure-related symptoms using ePRO (electronic Patient-Reported Outcome), with standard care (which does not promote symptom awareness) serving as the control. The primary outcome measure will be an intergroup comparison of changes over time in health-related quality of life (HRQL) as measured by the KCCQ-12. Secondary endpoints include clinical prognosis (readmission rate up to 24 weeks and severity at readmission), adherence, and HRQL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This trial will use ePRO to screen for heart failure related symptoms over time and will conduct a randomized controlled trial to evaluate the clinical utility of promoting symptom awareness, using standard care which does not promote symptom awareness as the control. For the two groups the intervention group, which received HFSPS to promote symptom awareness, and the control group general linear model will be fitted using the KCCQ12 overall summary score at 3 and 6 months as the response variable, and group, time, the interaction between group and time, and the baseline KCCQ12 overall summary score as explanatory variables.
Key secondary outcomes
Compare the KCCQ12 subscales Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitation using general linear models and the same methodology as in the primary analysis.Estimate and test for differences between the intervention and control groups in the BMQ TNS, TCS, and NCD scores at 24 weeks postdischarge.Summarize the proportion of HFSPS entries in the intervention group using descriptive statistics.Estimate and test for differences in the EFHScBS score at 24 weeks postdischarge between the intervention and control groups.Estimate and test for differences in DA and DAOH between the intervention and control groups.The time to first readmission for heart failure or any cause will be estimated using the Kaplan Meier method for survival analysis, and group comparisons will be performed using the logrank test. Additionally, the hazard ratio and 95 percent confidence interval will be calculated using the Cox proportional hazards model to evaluate the hazard ratio between groups.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
To promote symptom awareness, participants are asked to periodically complete the Heart Failure Physical Sensation Scale. Symptom assessments using ePRO are requested once a week for the first month after discharge, and then once every two weeks for the following six months.
Interventions/Control_2
In the control group, standard care is provided without the ePRO based symptom awareness intervention used in the intervention group.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.18 years of age or older
2.Diagnosed with heart failure and currently hospitalized
3.Written consent has been obtained from the patient
4.Able to enter ePRO data via Bring Your Own Device
Key exclusion criteria
1. Has cognitive difficulties that make it hard to complete the PRO questionnaire
2. Has mental health issues that make it hard to complete the PRO questionnaire
3. Does not speak Japanese as a native language
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | SUZUKI |
Organization
Teikyo Heisei University
Division name
Faculty of Pharmaceutical Sciences
Zip code
1648530
Address
4-21-2 Nakano, Nakano-ku, Tokyo
TEL
+81-3-5860-4711
ma.suzuki@thu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | SUZUKI |
Organization
Teikyo Heisei University
Division name
Faculty of Pharmaceutical Sciences
Zip code
1648530
Address
4-21-2 Nakano, Nakano-ku, Tokyo
TEL
+81-3-5860-4711
Homepage URL
ma.suzuki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Teikyo Heisei University
Address
2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
Tel
+81-3-5843-3152
rec@thu.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
| 2026 | Year | 04 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069749
