Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04733339 |
| Other study ID # |
2019-00864 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 11, 2019 |
| Est. completion date |
August 11, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Cereneo AG |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
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.
