Clinical trial NCT04470219: Digital Support for People With Cognitive Impairment
Official title: Digital Support for People With Cognitive Impairment - an Intervention to Increase Occupational Performance and the Possibility to Live a More Independent Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairments
Stroke
Brain Injuries
Keywords: Self-Help Devices
Occupational Therapy
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2020-07-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Occupational performance is assessed at baseline. Change from baseline in occupational performance is assessed after two months. And change from baseline after four months.
measure: Functional independence measure (FIM)
timeFrame: Independence is assessed at baseline. Change from baseline in independence is assessed after two months. And change from baseline after four months.
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: HQoL is assessed at baseline. Change from baseline in HQoL is assessed after two months. And change from baseline after four months
measure: Psychosocial Impact of Assistive Device Scale (PIADS)
timeFrame: 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.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Region of Ostergotland
state: Ostergotland
Study officials:
affiliation: Faculty of Medicine and Health Sciences Linkoping University
name: Tiny Jaarsma
role: PRINCIPAL_INVESTIGATOR
References: