Evaluating the Role of Step Counts in Predicting Readmission and Mortality

NCT06687330 | Completed

• 1 other identifier: E-77082166-604.01-1070182
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Association Between Daily Step Count and Recurrent Hospitalization

  To evaluate the relationship between daily step count, as recorded by a smartwatch, and the incidence of recurrent hospitalizations within 30 to 90 days post-discharge among oncology patients. The study aims to determine if lower daily step counts are associated with an increased risk of rehospitalization.

  6 months

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes oncology patients discharged from the inpatient ward after completing their treatment regimen. Eligible participants are adults (≥18 years) with various cancer types and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, indicating the ability to perform basic ambulatory activities. The cohort will be analyzed for the relationship between post-discharge physical activity-assessed through daily step counts, heart rate, and sleep duration-and the risk of readmission within 90 days. Exclusion criteria include patients with significant mobility limitations, cognitive or psychiatric impairments, or those admitted only for outpatient or same-day treatments.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Gazi University

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Nuriye Ozdemir, Prof. Dr.

  Gazi University

  STUDY CHAIR

• Osman Sutcuoglu, Associate Professor

  Ankara Etlik City Hospital

  STUDY DIRECTOR

• Orhun Akdogan, MD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncology Fellow

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: November 7, 2024
• Primary Completion: June 15, 2025
• Study Completion: August 15, 2025
• Last Updated: August 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)