Completed

SensE-MSensing Physical Activity to Evaluate and Monitor a Routine Aftercare Program (SensE-M) - an Observational Study

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Autoimmune Diseases+11

+ Behavior

+ Cardiovascular Diseases

Over 18 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2022
See protocol details

Summary

Principal SponsorUniversity of Zurich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 21, 2022

Actual date on which the first participant was enrolled.

Primary hypothesis (hypothesis 1 - effective integration): The investigators hypothesize that integrating the Fitbit effectively into the program to measure activity goals will support program participants in pursuing their daily activity goals, particularly, once they have returned home. A prerequisite for the Fitbit's effective integration into individuals' daily lives will be the definition of activity goals which can be measured and tracked conveniently with the Fitbit. Analysis plan: The analysis strategy will depend on the final sample size. Using a descriptive approach, the investigators will compute the difference between average daily activity after their return home and their predefined activity goals which have been defined as part of the 'Bliib dra'-program (e.g., active zone minutes of different intensity, steps per day) relative to previously agreed activity level goals. Furthermore, the investigators will examine participants' free text replies concerning challenges and facilitators in pursuing their activity goals in daily life and potential/difficulties of activity trackers in this regard. To extract relevant information, the investigators will evaluate Fitbit-related statements using natural language processing techniques. Secondary hypothesis (hypothesis 2 - daily-life activity at home): Further, the investigators hypothesize that program participants will maintain a consistent and relatively stable level of physical activity. Analysis plan: The analysis strategy will depend on the final sample size. The investigators will examine different activity level outcomes (e.g., active zone minutes, step count, high- /medium-intensity minutes) the time series data using descriptive and visual methods. If the sample size allows for more complex models, they will model physical activity over time and explore individual level-factors using a (multilevel) regression framework whereby controlling for individual-level factors. The investigators will investigate decline in activity levels defined as abrupt decrease or a steady decrease over an extended period of time (i.e., at least a week). Exploratory: The investigators will further explore what challenges program participants and therapists experience, what they appreciate, and what they need to effectively integrate activity trackers such as the Fitbit device effectively into routine care program 'Bliib dra'. They will also explore how individual-level health measures (e.g., PROMIS-10) change over time. Analysis plan: The investigators will examine therapists' and program participants' replies to the open questions using natural language processing techniques. With regard to the time series data, the analysis strategy will depend on the final sample size. They will examine the time series data using descriptive and visual methods. If the sample size allows for more complex models, the investigators will use a multivariable regression framework whereby controlling for individual-level factors.

Official TitleSensing Physical Activity to Evaluate and Monitor a Routine Aftercare Program (SensE-M) - an Observational Study
Principal SponsorUniversity of Zurich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesBehaviorCardiovascular DiseasesChronic DiseaseDemyelinating DiseasesImmune System DiseasesMotor ActivityMultiple SclerosisNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNSDisease Attributes

Criteria

2 inclusion criteria required to participate
Female and male inpatients who are for an inpatient stay at Kliniken Valens and participate in the 'Bliib dra'-program while the study is ongoing. The 'Bliib dra'-program is conceptualized for adult persons who have a diagnosis of MS, a cardiovascular disease, diabetes, stroke, or hypertension.

Provision of written informed consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Kliniken Valens

Valens, SwitzerlandOpen Kliniken Valens in Google Maps
CompletedOne Study Center