Cognitive ImpairmentsNCT04470219
Digital Support for People With Cognitive Impairment
A study testing Cognitive support by RemindMe in people with Cognitive Impairments and Stroke, run by Linkoeping University at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cognitive Impairments, Stroke, Brain Injuries
- What is being tested?
- Cognitive support by RemindMe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cognitive Impairments, Stroke, Brain Injuries
- Being tested
- Cognitive support by RemindMe
- Keywords
- Self-Help Devices, Occupational Therapy
- Medical subject headings
- Cognitive Dysfunction, Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive support by RemindMeOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study startOct 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tiny Jaarsma, Linkoeping University
- Investigators
- Tiny Jaarsma, Principal investigator, Faculty of Medicine and Health Sciences Linkoping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470219
- Sponsor's protocol ID
- RemindMe
- Status last verified
- Jul 2020
- First submitted
- 27 Mar 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study result will be presented in Peer reviewed Open access journal
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Support for People With Cognitive Impairment - an Intervention to Increase Occupational Performance and the Possibility to Live a More Independent Life
- ClinicalTrials.gov ID
- NCT04470219
- Acronym / sponsor ID
- RemindMe
- Conditions
- Cognitive Impairments, Stroke, Brain Injuries
- Keywords
- Self-Help Devices, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Cognitive support by RemindMeParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive support by RemindMe | Other | intervention group |
Primary outcome
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.
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.
2 secondary outcomes
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: Yes. Study result will be presented in Peer reviewed Open access journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiny Jaarsma principal investigator
Faculty of Medicine and Health Sciences Linkoping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive support by RemindMe in people with Cognitive Impairments and Stroke, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.