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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04470219
Other study ID # RemindMe
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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