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Stroke, IschemicNCT04733339

Investigating Adherence to Cereneo Tele-service Support After Clinical Disharge in Stroke Patients

An observational study of Stroke, Ischemic, run by Cereneo AG at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This observational, prospective cohort, pilot study aims at investigating usability, operational, and economical factors around 'traditional' and 'technology-supported' approaches to promote a healthy life-style in stroke survivors, after discharge from an in-patient clinic. Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke, Ischemic
What is being tested?
Secondary Prevention
How many people
2 participants
Where
1 siteSwitzerland
Study dates
11 Jul 2019to 11 Aug 2020
How long will I take part?
12 Months
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 20 stroke patients

Who may be able to join

  • Male or Female individuals above ≥ 18 years of age;
  • established diagnosis of the specific pathological condition - stroke
  • planned to be discharged from in-patient setting to their home
  • ability to give informed consent
  • can communicate in German, Italian or English

Who cannot join

  • are not medically stable (determined by the treating medical doctor)
  • cognitive disabilities as defined by MoCa < 20
  • have aphasia, dysarthria, apraxia or neglect and/or hemianopsia preventing them from conducting examinations, using tablet devices and/or receiving educational counselling
  • have dysphagia which requires close medical care
  • have clinically important musculoskeletal or other neurological conditions preventing them from using a tablet device
  • terminal condition
Show all 9Show fewer
  • Strong resistance towards risk factor education and nutritional guidance
  • no internet connection or telephone line and reachable internet provider at home
  • Social or personal circumstance, which interfere with the participation of the study

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • cereneo Schweiz AG | center for neurology & rehabilitation

    Vitznau, Canton of Lucerne, 6354

Other trials in Switzerland

About this study

Official title: Investigating Adherence to Cereneo Tele-service Support After Clinical Disharge in Stroke Patients- Observational, Pilot Study

This observational, prospective cohort, pilot study aims at investigating usability, operational, and economical factors around 'traditional' and 'technology-supported' approaches to promote a healthy life-style in stroke survivors, after discharge from an in-patient clinic.

The investigators primary objective is to evaluate the adherence to prescribed behavioral changes in dieting and exercising up to one year after clinical discharge. This pilot study will follow and document the observations of two groups of patients, one offered a 'traditional' and another one a 'technology-supported' approach by the healthcare provider.

The investigators secondary objective is to gain insights on how to efficiently (and securely) facilitate remote counselling once patients get discharged from the clinic.

Read the detailed description

The investigators will screen and randomize hospitalized patients at the cereneo Schweiz AG - center for neurology \& rehabilitation.

The participant will be informed that his/her medical records may be examined by authorized individuals other than their treating physician.

All participants for the study will be provided a participant information sheet and a consent form describing the study and providing enough information for participant to make an informed decision about their participation in the study. Patients will be given at least one day to make their decision. The formal consent of a participant, using the approved consent form, will be obtained before the participant is submitted to any study procedure.

The process from the admission to an in-patient clinic to home discharge will follow the routine procedures at the cereneo clinic.

During the clinical stay, non-modifiable (e.g. age, gender) and modifiable risk factors (e.g. blood values, blood pressure, diabetes) for stroke are assessed by an interdisciplinary team of health care providers . For present risk factors, causes among behavioral and psychosocial factors are investigated and possible behavioral changes are estimated.

The clinical team provides information and education during in-clinic consultations.

This study will pay particular attention to the counselling sessions related to exercising and dieting.

In terms of dieting a nutrition specialist helps patients create a personal plan to meet their needs. Food and nutritional care quality is assessed weekly and scored, so as to improve health institution efficacy in patient assistance. In-depth nutrition assessments may include evaluation of anthropometric, biochemical, and clinical data; evaluation of energy and nutrient intake at home or in the hospital; evaluation of access to food at home; calculation or measurement of energy and nutrient needs; and assessment of educational demand. All of this is done within the context of the patient's history of the present illness and treatments received. Within this phase, patients may be prescribed with special diets that are modified in macro- or micronutrients, consistency, nutrient or energy supplementation using liquid dietary supplements, vitamin and mineral supplements, enteral or parenteral nutrition support, or nutrition counselling.

In terms of exercising, movement therapists are assessing the patient's performance weekly and discuss possibilities for self-training homework exercises, considering the patient's health status and short-term therapy goals. Therapy exercises might be described on paper or video-taped for further independent training. Recommended activities might be conducted independently or with the help of the care team between therapy sessions.

Prior to discharge, a session between the medical team and the patient and his/her relatives (or main caregiver) is organized. Within such sessions, individual advices with respect to behavioral changes at home are discussed.

Individual goals including, but not limited to, exercising and dieting are discussed and set. General educational material including general guidelines in alcohol and tobacco consummation, overall activity, and general dietary recommendations are typically printed on paper and handed over to the patient.

After clinic discharge, it is understood that the in-patient clinic is no longer the main responsible for the patient maintaining a healthy lifestyle.

In this study, the investigators will provide (within the context of this study) additional medical support or tele-service, at no cost to the participants.

The Investigators will provide follow-ups video-calls and visits at predetermined timepoints, at no cost to the participants.

Two different service approaches will be investigated. One approach consists of a 'Traditional' approach, in which the healthcare provider (cereneo clinic) relies on traditional tools to provide a service (use of Electronic Medical Records, prescription of diet and exercising given on a piece of paper/or by in-person debriefing, phone calls, etc.). The second approach, 'Technology-supported', consists on the same approach, but with the aid of new technological tools (e.g. video-conference, exercise prescription and meal planner programs, activity tracking, etc.) to provide a better service to the patient.

Being tested
Secondary Prevention
Keywords
personalized nutrition, stroke, tele-service, exercising, rehabilitation, secondary prevention
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Secondary PreventionBehavioural

    behavioral changes in dieting and exercising up to one year after clinical discharge

Study groups in NCT04733339
Study groupRoleWhat they receive
'Traditional' group10 stroke patients
Receives: Behavioral: Secondary Prevention
'Technology-supported' group10 stroke patients
Receives: Behavioral: Secondary Prevention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to prescribed dieting

    Goal Attainment Scaling in Rehabilitation test

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2021
  2. Study start11 Jul 2019
  3. Primary completion11 Aug 2020
  4. Study completion11 Aug 2020

Why it stopped: COVI-19 Pandemic

Resources

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
2 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04733339
Sponsor's protocol ID
2019-00864
Other IDs
2019
Status last verified
Jan 2021
First submitted
12 Sep 2019
Last updated
2 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data not recorded on the CRF will be stored in a database or locally on the computers of different training devices or online if the device offers online processing. The link between the online processed data and the respective patient's identity is only known to authorized therapeutic personnel. All data not in the CRF is not study specific and is routinely recoded. The used database is embedded into the clinics patient administration system called Vitomed. The training devices record training data and store the data locally or online. Selected data of the devices relevant to the study will be copied and stored to the mentioned database or to the CRF if study specific, respectively. All the data storing systems besides the CRF are routinely used within the clinic.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Ischemic, run by Cereneo AG 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Feb 2021. 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 was stopped early (reason given: COVI-19 Pandemic). Results are not available in the source record.

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?

Adherence to prescribed dieting (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Feb 2021.

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