Disease With a Risk for ChronicitySensE-MNCT05243407
Sensing Physical Activity to Evaluate and Monitor a Routine Aftercare Program (SensE-M)
An observational study of Disease With a Risk for Chronicity, run by University of Zurich at 1 site in Switzerland.
Trial summary
Conditions such as multiple sclerosis (MS) and cardiovascular diseases (CVDs) are severe and prevalent health conditions which decrease life expectancy and increase morbidity. Key symptoms of MS and CVDs include restrictions in physical activity which increase over time and severely affect individuals' quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease With a Risk for Chronicity
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Feb 2022to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are at Kliniken Valens for an inpatient rehabilitation stay and participate in the 'Bliib dra'-program are eligible for the study. Program participants that are interested in the study will be provided with the study information sheet, detailing study aims and procedure. We will enroll patients if they agree to participate and provide written informed consent.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensing Physical Activity to Evaluate and Monitor a Routine Aftercare Program (SensE-M) - an Observational Study
Conditions such as multiple sclerosis (MS) and cardiovascular diseases (CVDs) are severe and prevalent health conditions which decrease life expectancy and increase morbidity. Key symptoms of MS and CVDs include restrictions in physical activity which increase over time and severely affect individuals' quality of life. As such, promoting physical activity is at the core of state-of-the-art treatment for these diseases. However, any improvements in daily activity levels and physical fitness that may be achieved are typically challenging to maintain in daily life. Once back in their daily life environment, persons with chronic diseases face multiple barriers to physical activity such as fatigue, a less structured environment, or time restrictions associated with care responsibilities, employment, or the like.
Thus, a key challenge relates to the effective adaptation of physical activity-promoting routines and structures from the supportive rehab clinic environment to individuals' everyday lives. An example of an inpatient routine aftercare program which is designed to bridge this transition is the 'Stay with it'-program (Swiss German: 'Bliib dra'-program) developed by the Kliniken Valens. The program is designed to empower participants and promote self-efficacy and expertise - for example, in terms of self-management and self-monitoring skills. In addition, novel types of consumer-grade sensors, such as the Fitbit activity tracker, allow the assessment of a broad range of real-time activity- and sleep-related features and could complement the routine aftercare program. While these technical developments facilitate personalization and tailoring of health programs, it is often an untapped resource. However, health care professionals face time- and resource constraints. Consequently, any technical extensions of routine care programs tapping novel technical resources would need to be very scalable, streamlined, and efficient.
Objectives: The present project will thus explore the potential of leveraging novel technical development in the form of consumer-grade activity sensors to complement a routine aftercare program aiming to translate structures and skills from the inpatient stay to individuals' daily lives. Specifically, the project will examine whether and how concomitant evaluation of the 'Bliib dra'-program is effective, feasible, accepted, and sustainable. To this end, we will carefully examine the experiences and needs of both program participants and therapists and conclude with recommendations which can be generalized to similar types of routine aftercare programs which are conceptualized for adult persons for whom maintenance and increase of physical activity is vital (e.g., MS, CD, other chronic diseases and acute conditions that are at risk for a chronic course such as stroke).
Read the detailed description
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.
- Conditions
- Disease With a Risk for Chronicity
- Keywords
- chronic disease, multiple sclerosis, cardiovascular disease, physical activity, activity tracker
- Medical subject headings
- Chronic Disease, Multiple Sclerosis, Cardiovascular Diseases, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Active zone minutes (Fitbit)
Rate of energy expended during an activity : rate of energy expended during rest
Measured: through study completion, on average 4 months
Step count (Fitbit)
Measured: through study completion, on average 4 months
Minutes spent in activity intensity levels (high, moderate, low; Fitbit)
Measured: through study completion, on average 4 months
Heart rate (Fitbit)
Measured: through study completion, on average 4 months
Answers to open questions for program participants and therapists regarding the implementation of the 'Stay with it'-program as well as their experience with the Fitbit
Measured: prior to program start, at clinic discharge (i.e., on average after 1 month), and 3-month follow-up
Secondary outcomes (2)
Patient-Reported Outcomes Measurement Information System - Global 10 (PROMIS-10)
Measured: at clinic admission, at clinic discharge (i.e., on average after 1 month), and 3-month follow-up
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Measured: prior to program start, at clinic discharge (i.e., on average after 1 month), and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start21 Feb 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Disease With a Risk for ChronicityStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Kliniken Valens
- Responsible party
- Sponsor
- Investigators
- Viktor von Wyl, Prof. Dr., Principal investigator, Institute for Implementation Science in Health Care, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243407
- Sponsor's protocol ID
- V1
- Acronym
- SensE-M
- Status last verified
- Apr 2023
- First submitted
- 28 Jan 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams V, Linke A. Impact of exercise training on cardiovascular disease and risk. Biochim Biophys Acta Mol Basis Dis. 2019 Apr 1;1865(4):728-734. doi: 10.1016/j.bbadis.2018.08.019. Epub 2018 Aug 28.
PubMed 30837069Brouns B, van Bodegom-Vos L, de Kloet AJ, Tamminga SJ, Volker G, Berger MAM, Fiocco M, Goossens PH, Vliet Vlieland TPM, Meesters JJL. Effect of a comprehensive eRehabilitation intervention alongside conventional stroke rehabilitation on disability and health-related quality of life: A pre-post comparison. J Rehabil Med. 2021 Mar 5;53(3):jrm00161. doi: 10.2340/16501977-2785.
PubMed 33369683Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, Giesser B, Halper J, Karpatkin H, Keller J, Ng AV, Pilutti LA, Rohrig A, Van Asch P, Zackowski K, Motl RW. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Mult Scler. 2020 Oct;26(12):1459-1469. doi: 10.1177/1352458520915629. Epub 2020 Apr 23.
PubMed 32323606Katzan I, Schuster A, Kinzy T. Physical Activity Monitoring Using a Fitbit Device in Ischemic Stroke Patients: Prospective Cohort Feasibility Study. JMIR Mhealth Uhealth. 2021 Jan 19;9(1):e14494. doi: 10.2196/14494.
PubMed 33464213Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63.
PubMed 20961442Silveira SL, Motl RW. Activity monitor use among persons with multiple sclerosis: Report on rate, pattern, and association with physical activity levels. Mult Scler J Exp Transl Clin. 2019 Nov 9;5(4):2055217319887986. doi: 10.1177/2055217319887986. eCollection 2019 Oct-Dec.
PubMed 31741742Van Geel F, Geurts E, Abasiyanik Z, Coninx K, Feys P. Feasibility study of a 10-week community-based program using the WalkWithMe application on physical activity, walking, fatigue and cognition in persons with Multiple Sclerosis. Mult Scler Relat Disord. 2020 Jul;42:102067. doi: 10.1016/j.msard.2020.102067. Epub 2020 Apr 18.
PubMed 32371377
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensing Physical Activity to Evaluate and Monitor a Routine Aftercare Program (SensE-M) - an Observational Study
- ClinicalTrials.gov ID
- NCT05243407
- Acronym / sponsor ID
- SensE-M / V1
- Conditions
- Disease With a Risk for Chronicity
- Keywords
- chronic disease, multiple sclerosis, cardiovascular disease, physical activity, activity tracker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Kliniken Valens
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conditions such as multiple sclerosis (MS) and cardiovascular diseases (CVDs) are severe and prevalent health conditions which decrease life expectancy and increase morbidity. Key symptoms of MS and CVDs include restrictions in physical activity which increase over time and severely affect individuals' quality of life. As such, promoting physical activity is at the core of state-of-the-art treatment for these diseases. However, any improvements in daily activity levels and physical fitness that may be achieved are typically challenging to maintain in daily life. Once back in their daily life environment, persons with chronic diseases face multiple barriers to physical activity such as fatigue, a less structured environment, or time restrictions associated with care responsibilities, employment, or the like.
Thus, a key challenge relates to the effective adaptation of physical activity-promoting routines and structures from the supportive rehab clinic environment to individuals' everyday lives. An example of an inpatient routine aftercare program which is designed to bridge this transition is the 'Stay with it'-program (Swiss German: 'Bliib dra'-program) developed by the Kliniken Valens. The program is designed to empower participants and promote self-efficacy and expertise - for example, in terms of self-management and self-monitoring skills. In addition, novel types of consumer-grade sensors, such as the Fitbit activity tracker, allow the assessment of a broad range of real-time activity- and sleep-related features and could complement the routine aftercare program. While these technical developments facilitate personalization and tailoring of health programs, it is often an untapped resource. However, health care professionals face time- and resource constraints. Consequently, any technical extensions of routine care programs tapping novel technical resources would need to be very scalable, streamlined, and efficient.
Objectives: The present project will thus explore the potential of leveraging novel technical development in the form of consumer-grade activity sensors to complement a routine aftercare program aiming to translate structures and skills from the inpatient stay to individuals' daily lives. Specifically, the project will examine whether and how concomitant evaluation of the 'Bliib dra'-program is effective, feasible, accepted, and sustainable. To this end, we will carefully examine the experiences and needs of both program participants and therapists and conclude with recommendations which can be generalized to similar types of routine aftercare programs which are conceptualized for adult persons for whom maintenance and increase of physical activity is vital (e.g., MS, CD, other chronic diseases and acute conditions that are at risk for a chronic course such as stroke).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are at Kliniken Valens for an inpatient rehabilitation stay and participate in the 'Bliib dra'-program are eligible for the study. Program participants that are interested in the study will be provided with the study information sheet, detailing study aims and procedure. We will enroll patients if they agree to participate and provide written informed consent.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Active zone minutes (Fitbit)
Time frame: through study completion, on average 4 months
Rate of energy expended during an activity : rate of energy expended during rest
Step count (Fitbit)
Time frame: through study completion, on average 4 months
Minutes spent in activity intensity levels (high, moderate, low; Fitbit)
Time frame: through study completion, on average 4 months
Heart rate (Fitbit)
Time frame: through study completion, on average 4 months
Answers to open questions for program participants and therapists regarding the implementation of the 'Stay with it'-program as well as their experience with the Fitbit
Time frame: prior to program start, at clinic discharge (i.e., on average after 1 month), and 3-month follow-up
2 secondary outcomes
Patient-Reported Outcomes Measurement Information System - Global 10 (PROMIS-10)
Time frame: at clinic admission, at clinic discharge (i.e., on average after 1 month), and 3-month follow-up
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: prior to program start, at clinic discharge (i.e., on average after 1 month), and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 30837069Adams V, Linke A. Impact of exercise training on cardiovascular disease and risk. Biochim Biophys Acta Mol Basis Dis. 2019 Apr 1;1865(4):728-734. doi: 10.1016/j.bbadis.2018.08.019. Epub 2018 Aug 28.
- Background: PubMed 33369683Brouns B, van Bodegom-Vos L, de Kloet AJ, Tamminga SJ, Volker G, Berger MAM, Fiocco M, Goossens PH, Vliet Vlieland TPM, Meesters JJL. Effect of a comprehensive eRehabilitation intervention alongside conventional stroke rehabilitation on disability and health-related quality of life: A pre-post comparison. J Rehabil Med. 2021 Mar 5;53(3):jrm00161. doi: 10.2340/16501977-2785.
- Background: PubMed 32323606Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, Giesser B, Halper J, Karpatkin H, Keller J, Ng AV, Pilutti LA, Rohrig A, Van Asch P, Zackowski K, Motl RW. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Mult Scler. 2020 Oct;26(12):1459-1469. doi: 10.1177/1352458520915629. Epub 2020 Apr 23.
- Background: PubMed 33464213Katzan I, Schuster A, Kinzy T. Physical Activity Monitoring Using a Fitbit Device in Ischemic Stroke Patients: Prospective Cohort Feasibility Study. JMIR Mhealth Uhealth. 2021 Jan 19;9(1):e14494. doi: 10.2196/14494.
- Background: PubMed 20961442Murray E, Treweek S, Pope C, MacFarlane A, Ballini L, Dowrick C, Finch T, Kennedy A, Mair F, O'Donnell C, Ong BN, Rapley T, Rogers A, May C. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010 Oct 20;8:63. doi: 10.1186/1741-7015-8-63.
- Background: PubMed 31741742Silveira SL, Motl RW. Activity monitor use among persons with multiple sclerosis: Report on rate, pattern, and association with physical activity levels. Mult Scler J Exp Transl Clin. 2019 Nov 9;5(4):2055217319887986. doi: 10.1177/2055217319887986. eCollection 2019 Oct-Dec.
- Background: PubMed 32371377Van Geel F, Geurts E, Abasiyanik Z, Coninx K, Feys P. Feasibility study of a 10-week community-based program using the WalkWithMe application on physical activity, walking, fatigue and cognition in persons with Multiple Sclerosis. Mult Scler Relat Disord. 2020 Jul;42:102067. doi: 10.1016/j.msard.2020.102067. Epub 2020 Apr 18.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viktor von Wyl, Prof. Dr. principal investigator
Institute for Implementation Science in Health Care, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease With a Risk for Chronicity, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active zone minutes (Fitbit) (time frame: through study completion, on average 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243407, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.