TELEPARK: Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic

Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani (Other)
Overall Status
Completed
CT.gov ID
NCT05476302
Collaborator
(none)
18
1
10
1.8

Study Details

Study Description

Brief Summary

Retrospective study to evaluate the effect of a remote cognitive-rehabilitative intervention during the Covid outbreak in subjects with Parkinson's disease.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive digital 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 Design

Study Type:
Observational
Actual Enrollment :
18 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Oct 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Cognitive digital treatment

Cognitive digital treatment in patients with Parkinson's disease

Other: Cognitive digital treatment
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.

Outcome Measures

Primary Outcome Measures

  1. changes in cognitive status [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.

Secondary Outcome Measures

  1. changes in cognitive domains [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).

  2. changes in thymic state [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS INRCA Hospital Ancona Italy 60127

Sponsors and Collaborators

  • Istituto Nazionale di Ricovero e Cura per Anziani

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Nazionale di Ricovero e Cura per Anziani
ClinicalTrials.gov Identifier:
NCT05476302
Other Study ID Numbers:
  • INRCA_004_2022
First Posted:
Jul 27, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Nazionale di Ricovero e Cura per Anziani
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022