Digital Support for People With Cognitive Impairment

NCT04470219 | Completed

• 1 other identifier: RemindMe
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairments; Stroke; Brain Injuries

Keywords

Self-Help Devices; Occupational Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• EQ-5D-5L

  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)

  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.

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

Cognitive support by RemindMe OTHER

intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Region of Ostergotland

Linköping, Östergötland County, 581 91, Sweden

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Tiny Jaarsma

  Faculty of Medicine and Health Sciences Linkoping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at the Faculty of Medicine and Health Sciences

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: July 14, 2020
• Study Start: October 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)