Clinical trial NCT04733339: Investigating Adherence to Cereneo Tele-service Support After Clinical Disharge in Stroke Patients
Official title: Investigating Adherence to Cereneo Tele-service Support After Clinical Disharge in Stroke Patients- Observational, Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke, Ischemic
Keywords: personalized nutrition
stroke
tele-service
exercising
rehabilitation
secondary prevention
Lead sponsor: Cereneo AG
Sponsor class: INDUSTRY
First posted: 2021-02-02
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 stroke patients

Brief 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.

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.

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.

Eligibility criteria: Inclusion criteria

* 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

Exclusion criteria:

* 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
* 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

Primary outcomes:
measure: Adherence to prescribed dieting
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vitznau
country: Switzerland
facility: cereneo Schweiz AG | center for neurology & rehabilitation
state: Lucern
Study officials:
affiliation: cereneo Schweiz AG | center for neurology & rehabilitation
name: Krizia Ferrini, PhD
role: PRINCIPAL_INVESTIGATOR
References: