Digital Support for People With Cognitive Impairment

July 13, 2020 updated by: Tiny Jaarsma, Linkoeping University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Ostergotland
      • Linköping, Ostergotland, Sweden, 581 91
        • Region of Ostergotland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intervention group
Participants receive rehabilitation as usual and training how to use RemindMe by personnel from the research group and an occupational therapist working at the rehabilitation clinic. The participants will use RemindMe for two months. The participants choose activities that he/she wishes to remember to carry out with support by RemindMe. An individual follow-up session will be conducted once a week by the occupational therapist to evaluate if the chosen activities were performed and discuss strategies for the continued use of RemindMe. After two months the participants decide if he/she wants to continue to use RemindMe.
Other: Cognitive support by RemindMe
NO_INTERVENTION: control group
The control group receive treatment as usual by the rehabilitation personnel, for example, occupational therapists give interventions that provide support for memory, it could be a paper calendar or other memory devices or strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Occupational performance is assessed at baseline. Change from baseline in occupational performance is assessed after two months. And change from baseline after four months.
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.
Independence is assessed at baseline. Change from baseline in independence is assessed after two months. And change from baseline after four months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
HQoL is assessed at baseline. Change from baseline in HQoL is assessed after two months. And change from baseline after four months
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Investigators

  • Principal Investigator: Tiny Jaarsma, Faculty of Medicine and Health Sciences Linkoping University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (ACTUAL)

July 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RemindMe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study result will be presented in Peer reviewed Open access journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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