NCT05378724

Brief Summary

The primary objective of this study is to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University Medical Center (MUMC+) and Radboud University Medical Center (Radboudumc) compared to patients who received physiotherapy before implementation of Hospital Fit. Secondary: to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent standing per day, average time spent lying/sitting per day, average number of transitions per day and the Modified Iowa Level of Assistance scale (mILAS) scores in hospitalised patients. Besides, the reach, efficacy, adoption, and implementation of using Hospital Fit as part of the physiotherapy treatment will be investigated from the perspective of both patients and healthcare professionals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 18, 2023

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

April 8, 2022

Last Update Submit

April 17, 2023

Conditions

Cardiovascular DiseasesOncologyActivation, Patient

Keywords

Physical activityeHealthAccelerometerHospitalizationEffectivenessProcess evaluation

Outcome Measures

Primary Outcomes (1)

  • Average time spent walking per day (minutes).

    Total number of minutes walking divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of nine days.

    Period between inclusion and discharge, with a maximum of nine days.

Secondary Outcomes (4)

  • Average time spent standing per day (minutes).

    Period between inclusion and discharge, with a maximum of nine days.

  • Average time spent lying/sitting per day (minutes).

    Period between inclusion and discharge, with a maximum of nine days.

  • Average number of transitions per day from a sedentary position (lying or sitting) to an active position (standing or walking).

    Period between inclusion and discharge, with a maximum of nine days.

  • Modified Iowa Level of Assistance scale (mILAS) scores per day.

    Period between inclusion and discharge, with a maximum of nine days.

Other Outcomes (7)

  • Reach - Participation: Percentage of users (patients) of Hospital Fit that is reached in the intervention phase

    Period between inclusion and discharge with a maximum of nine days

  • Reach - Representation: Patient characteristics of users and non-users in

    Period between inclusion and discharge with a maximum of nine days

  • Efficacy - Perceived efficacy

    Patient interviews at day of removal of accelerometer (=day of discharge or after max. 9 days of Hospital Fit use (whichever comes first)). Healthcareprofessional interviews: after the last patient has terminated the study (Jan.2023).

  • +4 more other outcomes

Study Arms (2)

Control group

NO INTERVENTION

All subjects eligible for inclusion in this study will receive usual care physiotherapy treatment. The number of treatment sessions and content of physiotherapy treatment sessions will depend on the diagnosis and needs of the individual patient. This study will not interfere with the content of the usual care physiotherapy treatment. Usual care physiotherapy sessions wil take approximately 20-30 minutes per session. They receive no additional intervention and will not use Hospital Fit as part of their physiotherapy treatment. The patients in the control group will receive an activity monitor to collect data about their physical activity levels. However, patients and their healthcare professionals will not receive feedback on patients' physical activity levels.

Intervention group

EXPERIMENTAL

Patients in the intervention group will receive usual care physiotherapy and us Hospital Fit additionally. At the end of the last physiotherapy treatment session before discharge, or after a maximum of nine days of study inclusion (whichever comes first), the physiotherapist will remove the activity monitor and data collection will end.

Device: Hospital Fit 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the Netherlands

Interventions

Hospital Fit 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the NetherlandsDEVICE

Hospital Fit consists of a smartphone app combined to the MOX accelerometer. Hospital Fit provides patients and physiotherapists direct feedback on patients' physical activity behavior. Individual goals regarding the number of minutes per day spent walking can be set by the therapist. Hospital Fit also gives patients insight into their own recovery process. During every treament, the physiotherapist will evaluate the extent of functional recovery. In addition, Hospital Fit will give physiotherapists the option of creating a patient-specific exercise program supported by videos. During every treatment session, the patient and physiotherapist will evaluate (and if necessary adapt) the amount of activity performed since the previous treatment, the extent of functional recovery and the exercise program.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old.
  • Receiving physiotherapy at the Medical Oncology Department or the Cardiology Department at the MUMC+ or Radboudumc.
  • Enough understanding of the Dutch language.
  • Owning a smartphone (operating system: at least iOS 13.0 or Android 8.0).
  • Able to use a smartphone app.
  • Able to walk independently 2 weeks before admission, as scored on the Functional Ambulation Categories (FAC \>3).

You may not qualify if:

  • A contraindication to walking (as reported by a medical specialist in the electronic medical record).
  • A contraindication to wearing an activity monitor, fixed by a hypoallergenic plaster at the upper leg (such as active bilateral upper leg infection, severe oedema or bilateral transfemoral amputation).
  • Admitted for cancers of the head and neck (i.e., cancer in the oral cavity, throat (pharynx), voice box (larynx), paranasal sinuses and nasal cavity, salivary glands).
  • Admitted with cardiac arrhythmia and hemodynamic instability requiring medication over 48 hours (i.e., beta blockers or noradrenaline) or invasive treatment (i.e., pacemaker or defibrillator implementation).
  • Mentally incapacitated subjects as reported by healthcare professionals in the medical record. When any doubt arises, the patient will be excluded.
  • Impaired cognition (delirium / dementia) as reported in the medical record by a healthcare professional. When any doubt arises, the patient will be excluded.
  • Unable to participate in the informed consent procedure or unable to provide written informed consent.
  • A life expectancy shorter than 3 months as mentioned by the medical specialist in the medical record.
  • Previous participation in this study.
  • Employed as physiotherapist, nurse or physician (assistant) at the Medical Oncology Department or the Cardiology Department.
  • Working at the MUMC+ or Radboudumc for at least one month.
  • No participation in care for patients at the Medical oncology Department or Cardiology Department during the intervention phase (e.g., absence or research employment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboudumc

Nijmegen, Gelderland, 6525 EZ, Netherlands

Location

MaastrichtUMC

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Cardiovascular DiseasesNeoplasmsPatient ParticipationMotor Activity

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Antoine F Lenssen, Prof, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: A prospective, multi-center, stepped-wedge cluster-randomised trial will be performed to investigate the effectiveness of Hospital Fit. Additionally, a process evaluation will be performed using semi-structured interviews and questionnaires in patients and focus-group interviews in healthcare professionals.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2022

First Posted

May 18, 2022

Study Start

August 1, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

April 18, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

We do not intent to make IPD available to other researchers.

Locations

NL(2)