Digital Support for People With Cognitive Impairment

Not Applicable

Completed

• Conditions: Cognitive Impairments; Stroke; Brain Injuries

• Registration Number: NCT04470219
• Lead Sponsor: Linkoeping University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Study First Submitted: 2020-03-27
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Study First Posted: 2020-07-14
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	Occupational performance is assessed at baseline. Change from baseline in occupational performance is assessed after two months. And change from baseline after four months.	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.
Functional independence measure (FIM)	Independence is assessed at baseline. Change from baseline in independence is assessed after two months. And change from baseline after four months.	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.

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L	HQoL is assessed at baseline. Change from baseline in HQoL is assessed after two months. And change from baseline after four months	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.
Psychosocial Impact of Assistive Device Scale (PIADS)	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.	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.

Trial Locations

Locations (1)

Region of Ostergotland; 🇸🇪 Linköping, Ostergotland, Sweden