Evaluating the Role of Step Counts in Predicting Readmission and Mortality

NCT ID: NCT06687330

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-07
• Study Completion Date: 2025-08-15

Brief Summary

This study investigates the relationship between physical activity, heart rate, and sleep quality with recurrent hospitalizations among discharged oncology patients. Following discharge, patients will wear Huawei smartwatches to enable daily tracking of step count, heart rate, and sleep duration through a connected smartphone app. Patients will also complete the FACT Quality of Life Survey and the Pittsburgh Sleep Quality Index during follow-up visits. The smartwatch monitoring will occur during the first 30 days post-discharge, while overall patient follow-up will extend up to 90 days. This study aims to determine if lower levels of home mobility, as indicated by step count and other activity metrics, correlate with an increased risk of hospital readmission within the 30-90 day period.

Detailed Description

This observational study aims to investigate the relationship between post-discharge mobility metrics and the likelihood of recurrent hospitalizations among oncology patients. Eligible participants include those who have completed treatment in the oncology ward and have an ECOG performance status of 0-2. Patients admitted only for day treatments or with significant mobility limitations are excluded. Each patient receives a Huawei Watch Fit 2 smartwatch at discharge to record daily step counts, heart rate, and sleep duration, monitored remotely through a smartphone application.

In addition to these mobility and physiological metrics, patient-specific factors-such as diagnosis, reason for admission, date of last treatment, cancer stage, and age-are collected, as these may influence follow-up outcomes. Participants complete the FACT Quality of Life Survey and the Pittsburgh Sleep Quality Index at two time points: prior to discharge and again at follow-up, enabling a comparative assessment of quality of life and sleep quality over time. All patients receive general walking recommendations to support their recovery.

During the first 30 days post-discharge, activity and physiological data are continuously monitored through the app. The follow-up period extends to 90 days, during which any hospital readmissions are recorded. By analyzing trends in step count, sleep patterns, and heart rate variability, the study aims to determine whether decreased home mobility is associated with a higher risk of readmission, potentially enabling earlier interventions for at-risk individuals.

Participant recruitment for this study was completed ahead of schedule due to a higher-than-anticipated rate of eligible patient enrollment. The study is currently in the follow-up phase, and data collection for outcome measures is ongoing. The anticipated primary completion date is June 15, 2025.

Conditions

Exercise; Smart Watch; Quality of Life (QOL); Sleep Quality; Rehospitalization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Tracking Mobility and Health Data with a Smartwatch in Discharged Oncology Patients to Predict Rehospitalization: A Prospective Study

The intervention involves daily monitoring of discharged oncology patients using a smartwatch (Huawei Watch Fit 2) to track physical activity (step count), heart rate, and sleep duration. Data is collected remotely via a smartphone app, allowing real-time tracking of health metrics post-discharge. This intervention is distinct in its focus on correlating mobility and physiological data with the risk of rehospitalization within a 30-90 day period. Patients will also receive recommendations to maintain daily walking routines as part of their post-discharge care. Additionally, quality of life and sleep quality assessments are conducted before discharge and at follow-up visits to provide a comprehensive overview of each patient's post-hospital recovery.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age: 18 years and older.
• Oncology Ward Discharge: Patients who have been discharged from the oncology ward following inpatient treatment.
• Cancer Diagnosis: Patients diagnosed with any form of cancer who received treatment in the oncology ward.
• Treatment Completion: Patients who have completed their scheduled inpatient oncology treatment and have been discharged.
• Performance Status: Patients with an ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2, indicating they are ambulatory and capable of basic physical activity.
• Follow-Up Availability: Patients who are willing and able to participate in a 90-day follow-up period after discharge.
• Technology Compliance: Patients who agree to wear a Huawei Watch Fit 2 smartwatch for the first 30 days post-discharge to track daily step count, heart rate, and sleep duration, and have access to a compatible smartphone for remote data monitoring.
• Survey Participation: Patients willing to complete the FACT Quality of Life Survey and Pittsburgh Sleep Quality Index before discharge and during follow-up visits.

Exclusion Criteria

• Day Treatment Admissions: Patients admitted exclusively for day treatments or outpatient procedures, lacking a full inpatient admission in the oncology ward.
• Severe Mobility Limitations: Individuals with substantial mobility impairments, rendering them unable to perform basic ambulatory activities such as walking.
• Incompatibility with Technology Requirements: Patients who are unable or unwilling to wear the Huawei Watch Fit 2 smartwatch for data collection purposes or who lack access to a compatible smartphone for remote monitoring.
• Non-Adherence to Follow-Up Protocol: Patients who are unwilling or unable to comply with the 90-day follow-up requirements post-discharge.
• Incomplete Oncology Treatment Course: Individuals who have not completed the intended course of oncology treatment within the oncology ward prior to discharge.
• Cognitive or Psychiatric Impairments: Patients with significant cognitive or psychiatric disorders that impair their ability to provide informed consent or adhere to study protocols.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Orhun Akdoğan

Medical Oncology Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuriye Ozdemir, Prof. Dr.

Role: STUDY_CHAIR

Gazi University

Osman Sutcuoglu, Associate Professor

Role: STUDY_DIRECTOR

Ankara Etlik City Hospital

Orhun Akdogan, MD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Gazi University

Ankara, Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-77082166-604.01-1070182

Identifier Type: -

Identifier Source: org_study_id