Skip to main content
OpenTrials
Completed

NCT Number: NCT04470219

Digital Support for People With Cognitive Impairment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Impairments Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurocognitive Disorders Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region of Ostergotland

Linköping, Östergötland County, 581 91, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive support by RemindMe

Other

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: 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.

  2. Functional independence measure (FIM)

    Time frame: 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 outcomes

  1. EQ-5D-5L

    Time frame: 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.

  2. Psychosocial Impact of Assistive Device Scale (PIADS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2020
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.