Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733339
Status:
TERMINATED
Last Update Posted:
2021-02-02
First Post:
2019-09-12
Brief Title:
Investigating Adherence to Cereneo Tele-service Support After Clinical Disharge in Stroke Patients
Sponsor:
Cereneo AG
Organization:
Cereneo AG
Study Overview
Official Title:
Investigating Adherence to Cereneo Tele-service Support After Clinical Disharge in Stroke Patients- Observational Pilot Study
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVI-19 Pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 hisher 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 eg age gender and modifiable risk factors eg 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 patients 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 patients performance weekly and discuss possibilities for self-training homework exercises considering the patients 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 hisher 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 paperor 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 eg video-conference exercise prescription and meal planner programs activity tracking etc to provide a better service to the patient
The participant will be informed that hisher 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 eg age gender and modifiable risk factors eg 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 patients 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 patients performance weekly and discuss possibilities for self-training homework exercises considering the patients 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 hisher 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 paperor 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 eg video-conference exercise prescription and meal planner programs activity tracking etc to provide a better service to the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None