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

NCT04733339 | Terminated DMC

• 1 other identifier: 2019-00864
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

personalized nutrition; stroke; tele-service; exercising; rehabilitation; secondary prevention

Outcome Measures

Primary Outcomes (1)

• Adherence to prescribed dieting

  Goal Attainment Scaling in Rehabilitation test

  12 months

Study Arms (2)

'Traditional' group

10 stroke patients

Behavioral: Secondary Prevention

'Technology-supported' group

10 stroke patients

Behavioral: Secondary Prevention

Interventions

Secondary Prevention BEHAVIORAL

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

'Technology-supported' group; 'Traditional' group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

20 stroke patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cereneo AG: lead

Study Sites (1)

cereneo Schweiz AG | center for neurology & rehabilitation

Vitznau, Canton of Lucerne, 6354, Switzerland

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Krizia Ferrini, PhD

  cereneo Schweiz AG | center for neurology & rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: February 2, 2021
• Study Start: July 11, 2019
• Primary Completion: August 11, 2020
• Study Completion: August 11, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: All study data will be archived for a minimum of 10 years after study termination or premature termination of the study. Biological material in this project is not identified by participant name but by a unique participant number. Biological material will be sent abroad in the scope of the research project, if the participant involved has given his/her consent to do so upon having been sufficiently informed (HRO, Section 2). The original medical records in the eKardex of cereneo are subject to the data protection policy of the informatics division of the clinic. The paper CRFs as well as the printouts of the interim data analysis results in Excel™, SPSS™, Matlab™ (or similar software) will be stored in a locked archive room of the cereneo center for neurology and rehabilitation.
• Access Criteria: The CRF will be kept in a locked deposit in the study site. Only authorized personnel by the study will have access. The database of the clinics administration software can only be accessed by authorized therapeutic and administrational staff of the clinic. Only the clinics IT administrators have access to the database backups and change logs. Anthropometric assessments and nutrition status data, usability test of the application , satisfaction test of the log of meal planning app (provided by the AAL LIFANA project) will be compiled into a master file and pseudonymized. This anonymized and coded data within the master file will be shared with the Luxemburg Institute of Health (LIH) and Luxemburg Institute of Science and Technology (LIST) for statistical evaluation and interpretation, as part of the AAL LIFANA (Lifelong Food and Nutrition Assistance) project, which partially sponsors this study.

Locations

CH (1)