Evidence map›Paper›PMID 40976676›Full record

ArticleBMJ open2025

Effectiveness of innovative health enhancement and cardiac rehabilitation support programme combining a personal health record app and counselling services for patients with ischaemic heart disease: a study protocol for a randomised controlled trial.

Satoshi Yoshimura, Tomonari Shimamoto, Yukiko Tateyama, Miyuki Yazawa, Makoto Namba, Norihiro Nishioka, Yoshimitsu Takahashi, Takeo Nakayama, Taku Iwami

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Satoshi YoshimuraDepartment of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan.ORCID http://orcid.org/0000-0003-3490-2101
Tomonari ShimamotoDepartment of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan.
Yukiko TateyamaDepartment of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan.
Miyuki YazawaSaiseikai Karatsu Byoin, Karatsu, Japan.
Makoto NambaDepartment of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan.
Norihiro NishiokaDepartment of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan.ORCID http://orcid.org/0000-0001-5218-9819
Yoshimitsu TakahashiDepartment of Implementation Science in Public Health, School of Public Health, Kyoto University, Kyoto, Japan.
Takeo NakayamaDepartment of Health Informatics, School of Public Health, Kyoto University, Kyoto, Japan.
Taku IwamiDepartment of Preventive Services, School of Public Health, Kyoto University, Kyoto, Japan iwami.taku.8w@kyoto-u.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIschaemic heart disease (IHD) is a leading cause of morbidity and mortality worldwide. Despite strong recommendations, the implementation rate of outpatient cardiac rehabilitation (CR) in Japan remains low. Mobile health technologies, such as Personal Health Record (PHR) applications combined with wearable devices, may enhance adherence to rehabilitation programmes. This study aims to evaluate the effectiveness of a continuous support programme that integrates a PHR app and counselling services in improving the continuation rate of outpatient CR and exercise tolerance in patients with IHD. METHODS AND ANALYSIS: This is a single-blind randomised controlled trial with a parallel-group design. A total of 72 participants with IHD will be recruited from the outpatient departments of Maebashi Red Cross Hospital, Gunma Saiseikai Maebashi Hospital, Okayama University Hospital, Okayama Red Cross Hospital, Momoyama-kai Ono Internal Clinic, Hiroshima University Hospital, Tshuyama Jifu-kai Tsuyama Chuo Hospital and Shinpu-kai Tamashima Chuo Hospital. Participants will be randomly allocated to either the intervention group, which will receive a wearable device, a PHR app, counselling services and a rehabilitation notebook, or the control group, which will receive a wearable device and a rehabilitation notebook without the PHR app and counselling. The primary outcome is the change in peak oxygen uptake from baseline to 150 days. Secondary outcomes include changes in anaerobic threshold, number of outpatient rehabilitation visits, daily steps and vital signs. Data will be analysed using a generalised estimating equations for primary outcomes and appropriate statistical tests for secondary outcomes, following an intention-to-treat approach. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the ethics committee of the Kyoto University Graduate School and Faculty of Medicine (C1669-1). In addition, permission to conduct the study was granted by the director of each participating institution. Participants will provide informed consent prior to participation. Findings will be disseminated through peer-reviewed journals, conferences and summary reports to stakeholders. TRIAL REGISTRATION NUMBER: This trial is registered with the University hospital Medical Information Network (UMIN) Clinical Trials Registry (trial identifier: UMIN000055823).

Indexed as

Cardiac RehabilitationCounselingMobile ApplicationsMyocardial IschemiaExercise ToleranceFemaleHumansJapanMaleMiddle AgedRandomized Controlled Trials as TopicSingle-Blind MethodDigital TechnologyIschaemic heart diseaseREHABILITATION MEDICINE

Identifiers

PMID40976676
PMCPMC12458744

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.