- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05476302
Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic (TELEPARK)
July 26, 2022 updated by: Istituto Nazionale di Ricovero e Cura per Anziani
Retrospective study to evaluate the effect of a remote cognitive-rehabilitative intervention during the Covid outbreak in subjects with Parkinson's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Mild cognitive impairment is frequent among people with Parkinson's disease.
Cognitive training seems effective on cognitive status and for mitigating anxiety and depression.
With COVID-19 outbreak, such therapeutic interventions were delivered online.
This retrospective study was aimed at evaluating the effectiveness of an online cognitive treatment, carried out in COVID times and based on the Parkinson's-Adapted Cognitive Stimulation Therapy, on cognitive domains and mood in 18 older people with Parkinson's disease.
Study Type
Observational
Enrollment (Actual)
18
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ancona, Italy, 60127
- IRCCS INRCA Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Parkinson's disease that, after eight months of COVID-19 lockdown when all interventions were suspended, received an intensive digital cognitive rehabilitation treatment.
Description
Inclusion Criteria:
- Parkinson disease: Hoehn & Yahr's scale: 1-3 based on the UK PD Society Brain Bank
- mild cognitive impairment
- no cognitive training between March and October 2020
- presence of a family caregiver to access and use the online platform
Exclusion Criteria:
- other neurological diseases
- deep brain stimulation
- schizophrenia
- depression
- sensory deprivations that could interfere with the treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cognitive digital treatment
Cognitive digital treatment in patients with Parkinson's disease
|
The remote cognitive-rehabilitation treatment was based on Parkinson's adapted cognitive stimulation therapy (CST).
Fourteen twice-weekly sessions were planned, followed by one session per week for a duration of six months for maintenance therapy.
The treatment took place in groups of 4 patients in remote mode through the Microsoft-Teams platform.
All subjects maintained the prescribed drug therapy and regular physiotherapy activity during the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in cognitive status
Time Frame: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
The Mini Mental State Examination (MMSE) was used to evaluate the cognitive status.The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function.
|
This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in cognitive domains
Time Frame: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
The Addembrooke's Cognitive Examination Battery (ACE-R) was used to evaluate the cognitive domains.
The ACE-R consists of six components evaluating separate cognitive domains.
A maximum score of 100 is weighted as follows: orientation (10), attention (8), memory(35), verbal fluency (14), language (28), and visuospatialability (5).
|
This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
changes in thymic state
Time Frame: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
The Geriatric Depression Scale-15 items (GDS-15 items) was used to evaluate the tymic state.This instrument evaluated depressive symptoms using yes/no answers.
Scores range between 0 and 15 points.
Higher scores indicate more severe depressive symptoms.
|
This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
October 31, 2020
Study Completion (Actual)
October 31, 2020
Study Registration Dates
First Submitted
July 22, 2022
First Submitted That Met QC Criteria
July 26, 2022
First Posted (Actual)
July 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 26, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Cognition Disorders
- COVID-19
- Parkinson Disease
- Cognitive Dysfunction
Other Study ID Numbers
- INRCA_004_2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on Cognitive digital treatment
-
Shanghai 10th People's HospitalCompleted
-
Universidade Federal do Rio de JaneiroUnknownAging | Mild Cognitive ImpairmentBrazil
-
University of FloridaNational Institute on Aging (NIA); National Center for Advancing Translational...RecruitingCognitive DysfunctionUnited States
-
Akili Interactive Labs, Inc.CompletedAttention Deficit Hyperactivity DisorderUnited States
-
Beijing Anzhen HospitalBeijing Wispirit Technology Co., LtdActive, not recruitingCoronary Heart Disease | Mild Cognitive ImpairmentChina
-
St. Olavs HospitalUniversity of California, Berkeley; Norwegian University of Science and Technology and other collaboratorsActive, not recruiting
-
Vicore Pharma ABCurebase Inc.Active, not recruitingGeneralized Anxiety Disorder | Pulmonary FibrosisUnited States
-
Peking University First HospitalShenzhen Zeen Health Technology Co., Ltd.Not yet recruiting
-
Joint AcademyLund UniversityRecruitingHand Osteoarthritis | Thumb Osteoarthritis | Wrist Osteoarthritis | Finger OsteoarthritisSweden
-
Yale UniversityNational Center for Complementary and Integrative Health (NCCIH)RecruitingSubstance Use DisordersUnited States