Digital Support for People With Cognitive Impairment

Stroke Clinical Trial

Official title:

Digital Support for People With Cognitive Impairment - an Intervention to Increase Occupational Performance and the Possibility to Live a More Independent Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470219
• Other study ID #: RemindMe
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: July 2020
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cognitive impairment may cause problems in planning and initiating daily activities, as well as remembering to do what is scheduled. This study investigates the effectiveness of an interactive web-based mobile reminder calendar, (RemindMe). The calendar sends text messages to the user's mobile phone as support in everyday life, for persons with cognitive impairment due to neurological injury/diagnoses. The study has a randomized controlled trial design with data collection at baseline and at follow-up sessions after two and four months. Data collection started in October 2016 and continued until February 2018. RemindMe may give the needed support to remind the person and thus increase the ability to perform activities and to become independent in everyday life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Participants with cognitive impairment after stroke or other neurological diseases/injury

• Participants experiencing the need for support in planning, organizing and remembering to do activities in everyday life

• Participants having access to a computer and mobile phone/smartphone

• Participants having linguistic ability to participate in assessments

Exclusion Criteria:

• Participants with palliative care needs

• Participants with reduced vision and/or hearing loss that affects the ability to use a mobile phone/smartphone

• Participants with depression or psychiatric illness

Related Conditions & MeSH terms

• Brain Injuries
• Cognitive Dysfunction
• Cognitive Impairments
• Stroke

Intervention

Other:
• Cognitive support by RemindMe

Locations

Country	Name	City	State
Sweden	Region of Ostergotland	Linköping	Ostergotland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canadian Occupational Performance Measure (COPM)	The assessment is used to identify and measure performance and satisfaction with the performance of activities of daily living that are important to the person. Assessment is made on a scale from 1 to 10. 1 is the worst outcome and 10 is the best outcome.	Occupational performance is assessed at baseline. Change from baseline in occupational performance is assessed after two months. And change from baseline after four months.
Primary	Functional independence measure (FIM)	The assessment is used to identify and measure independence in everyday Life activities. Assessment is made on a scale from 1 to 7. 1 is the worst outcome and 7 is the best outcome.	Independence is assessed at baseline. Change from baseline in independence is assessed after two months. And change from baseline after four months.
Secondary	EQ-5D-5L	The assessment is used to assess Health-related Quality of Life (HQoL). Assessment is made on a Visual Analog Scale from 1 to 100. 1 is the worst outcome and 100 is the best outcome.	HQoL is assessed at baseline. Change from baseline in HQoL is assessed after two months. And change from baseline after four months
Secondary	Psychosocial Impact of Assistive Device Scale (PIADS)	The assessment is used to assess an Assistive Device Psychosocial impact on a person. Assessment is made on a scale from -3 to 3. -3 is the worst outcome, 0 is neutral impact and 3 is the best outcome.	The psychosocial impact is assessed at baseline. Change from baseline in psychosocial impact is assessed after two months. And change from baseline after four months.