UMIN-ICDS Clinical Trial

Public title

Evaluation of a Help-Seeking Support Program for Symptom Management in Older Patients with Heart Failure

Acronym

HSSP-HF Eval

Scientific Title

Preliminary Case-Based Evaluation of a Help-Seeking Support Program for Symptom Management in Older Patients with Heart Failure

Scientific Title:Acronym

HSSP-HF Eval

Region

Japan

Condition

heart failure

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate a help-seeking support program for older patients with heart failure by applying the program to clinical cases.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Scores on the Help-Seeking Behavior Scale (HSBS) for older patients with heart failure, assessed at four time points-hospital admission (recovery phase), before discharge, 2-4 weeks after discharge, and 3-4 months after discharge.

Key secondary outcomes

Participants' statements documented in field notes and help-seeking-related activities, assessed at four time points-hospital admission (recovery phase), before discharge, 2-4 weeks after discharge, and 3-4 months after discharge, as well as the post-intervention program usefulness evaluation form, collected after the intervention.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Provision of an education and counseling program by expert nurses to facilitate help-seeking among patients with heart failure.

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

Age-lower limit

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Eligible participants were patients aged 75 years or older with Stage C heart failure who were hospitalized for worsening heart failure and were expected to continue outpatient follow-up at the same institution after discharge. Patients were eligible if the attending physician determined that participation in the study would impose minimal physical and psychological burden. In addition, participants were required to have adequate cognitive function to independently decide whether to participate in the study and to understand and complete the questionnaire. All participants received an explanation of the study and provided written informed consent before enrollment.

Key exclusion criteria

Exclusion criteria were as follows: (1) patients with heart failure other than those classified as Stage C according to the ACC/AHA heart failure staging system; (2) patients who were unable to independently decide whether to participate in the study, provide written informed consent, or complete the study questionnaires; and (3) patients who were considered unlikely to complete the intervention or the study questionnaires during scheduled outpatient follow-up visits at 1 month and 3-4 months after hospital discharge.

Target sample size

8

Name of lead principal investigator

1st name	Masami
Middle name
Last name	Nakamura

Organization

Osaka Metropolitan University

Division name

School of Nursing

Zip code

5450051

Address

1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan

TEL

+81-6-6645-9011

Email

mas-nakamura@omu.ac.jp

Name of contact person

1st name	Masami
Middle name
Last name	Nakamura

Organization

Osaka Metropolitan University

Division name

School of Nursing

Zip code

5450051

Address

1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan

TEL

+81-6-6645-9011

Homepage URL

Email

mas-nakamura@omu.ac.jp

Institute

Osaka Metropolitan University

Institute

Department

Personal name

Organization

Osaka Metropolitan University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Kindai University, Higashi Takarazuka Satoh Hospital, Nagoya Heart Center

Name of secondary funder(s)

Kindai University

Organization

Osaka Metropolitan University

Address

1-4-3 Asahi-machi, Abeno-ku, Osaka, Japan

Tel

+81-6-6645-9011

Email

mas-nakamura@omu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

08

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

01

Month

26

Day

Date of IRB

2026

Year

06

Month

26

Day

Anticipated trial start date

2026

Year

08

Month

01

Day

Last follow-up date

2027

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

08

Month

07

Day

Last modified on

2026

Year

08

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071518