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Digital Support for People With Cognitive Impairment

Primary Purpose

Cognitive Impairments, Stroke, Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive support by RemindMe
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cognitive Impairments focused on measuring Self-Help Devices, Occupational Therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Region of Ostergotland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 27, 2020
Last Updated
July 13, 2020
Sponsor
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT04470219
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairments, Stroke, Brain Injuries
Keywords
Self-Help Devices, Occupational Therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive support by RemindMe
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
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.
Title
Functional independence measure (FIM)
Description
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.
Time Frame
Independence is assessed at baseline. Change from baseline in independence is assessed after two months. And change from baseline after four months.
Secondary Outcome Measure Information:
Title
EQ-5D-5L
Description
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.
Time Frame
HQoL is assessed at baseline. Change from baseline in HQoL is assessed after two months. And change from baseline after four months
Title
Psychosocial Impact of Assistive Device Scale (PIADS)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiny Jaarsma
Organizational Affiliation
Faculty of Medicine and Health Sciences Linkoping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region of Ostergotland
City
Linköping
State/Province
Ostergotland
ZIP/Postal Code
581 91
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study result will be presented in Peer reviewed Open access journal

Learn more about this trial

Digital Support for People With Cognitive Impairment

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