Mild Cognitive ImpairmentNCT06309758
BreinZorg: Feasibility Study Into an Online Lifestyle Platform for MCI and SCD
A study testing Breinzorg in people with Mild Cognitive Impairment and Cognitive Decline, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Dementia is the most common disease in older individuals and this century's biggest healthcare challenge. Many patients who visit the memory clinic with memory complaints do not have dementia but instead are diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD). Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Cognitive Decline
- What is being tested?
- Breinzorg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Apr 2024to 15 Jun 2025
- 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 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visited a memory clinic;
- Recent (no longer than 4 months) diagnosis of MCI or SCD according to the guidelines used in the memory clinic;
- >60 years of age;
- Sufficient fluency in Dutch;
- Internet access at home and a working e-mail address;
- Sufficient hearing and vision to read, watch and hear content on the website.
Who cannot join
- Diagnosis of Dementia according to the guidelines of the memory clinic;
- Any condition to hinder successful 6-month follow-up;
- Diagnosis of Major depression;
- Coincident participation in any other intervention trial at time of pre-screening.
Trial locations and contacts
1 site in 1 country.
Jurgen Claassen, Dr. contact
Netherlands1 site, 1 recruiting
- Recruiting
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
Tanya Palsma, MSc, 0243639609, tanya.palsma@radboudumc.nl
Jurgen Claassen, Dr., jurgen.Claassen@radboudumc.nl
About this study
Official title: BreinZorg: A Feasibility Study Into an Online Lifestyle Platform for Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD)
Dementia is the most common disease in older individuals and this century's biggest healthcare challenge. Many patients who visit the memory clinic with memory complaints do not have dementia but instead are diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD). MCI or SCD may be a pre-dementia stage. Many patients with MCI or SCD often leave their consultation with unanswered questions, and unsure what they, themselves can do to reduce dementia risk. Patients with MCI and SCD have a heightened risk of developing dementia. Therefore, this group would possibly benefit most from preventive strategies. Around 40% of dementia cases is attributable to modifiable factors. Thus, managing a healthy lifestyle may reduce dementia risk.
To answer the information request many patients have when leaving the memory clinic and to fill the knowledge gap an online tool has been developed.
Read more
The goal of this mixed-method feasibility study is to investigate the usability, feasibility, patient experience, and effectiveness of the personalized, multi-domain online website in older adults with MCI or SCD.
The main questions it aims to answer are:
- Is the new website being used by the target population?
- How does the target population experience the use of the website?
- What is the effect of using the website?
Participants will have access to the website and are free to use the website in any way they want.
- Conditions
- Mild Cognitive Impairment, Cognitive Decline
- Being tested
- Breinzorg
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreinzorgOther
The BreinZorg multidomain lifestyle website comprises 16 domains, namely (1) physical activity, (2) healthy diet, (3) smoking, (4) alcohol, (5) sleep, (6) cognitive activity (7) social activity, (8) diabetes, (9) blood pressure, (10) cholesterol, (11) heart- and vascular diseases, (12) kidney diseases, (13) hearing damage, (14) obesity, (15) anxiety, and (16) depression. These 16 modules are separated into three big themes: mood, lifestyle, and body.
Each module consists of the following:
- General information on the risk factor;
- Tips on how to improve and decrease the risk;
- Quiz questions about the risk factor, giving extra knowledge/ in a playful and interactive manner;
- Examples of SMART goals fitting the risk factor (goal examples are given in a Specific, Measurable, Achievable, Relevant, and Time-Bound manner).
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | 3 month active use of the website. Receive bi-weekly update mails to nudge participants to use the website. Receives: Other: Breinzorg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the new online website following the theoretical framework of acceptability
The perception among the patients that the intervention (website) is agreeable. The investigators collect data by means of a questionnaire following the theoretical framework of acceptability. Assessing 7 constructs of acceptability: Affective attitude, Burden, Ethicality, Perceived effectiveness, intervention coherence, self-efficacy and, opportunity costs. Additionally, qualitative information is on experiences and acceptability is gathered using semi-structured interviews.
Measured: After 3 months
Adoption / Uptake of the new online website. Website usage data.
The intention, initial decision, or action to try to employ a new intervention. How much and how is the new website used by the participants? The investigators collect monitoring data of the website on usage of the website.
Measured: After 3 months and after 6 months
Demand of the new online website. Website usage data.
The estimated use or actual use of the intervention.Monitoring data on the use of the website. How much time do participants spend on the website, which pages do they use and how many times do they visit the website?
Measured: After 3 months and after 6 months
Practicality of the new online website.
The extent to which the intervention can be delivered. Interviews in a subgroup will contain questions on the burden and barriers of the website. It will also contain questions on the desired frequency, duration, and intensity of the website.
Measured: After 3 months
Feeling of trust in yourself and your own abilities.
Effectiveness of the website in increasing feelings of self-efficacy. This is measured by the General Self-Efficacy Scale (GSES) questionnaire.
The scale goes from 'totally do not agree' to 'totally agree'. A higher score on this questionnaire means the participant has more feeling of trust in themselves and their abilities. scores will range between 10 and 50.
Measured: At baseline, after 3 months and after 6 months
Feeling of control about own life and future.
Effectiveness of the website in increasing feeling of control. This is measured by the 7-item Pearlin Mastery Scale.
The scale goes from 'totally do not agree' to 'totally agree'. A higher score on this questionnaire means the participant has more feeling of control. scores will range between 7 and 35.
Measured: At baseline, after 3 months and after 6 months
Motivation to change lifestyle for reduction of dementia risk.
Effectiveness of the website in increasing motivation to make lifestyle changes. This is measured by the Dutch Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction (MCLHB-DRR) questionnaire.
The answers to this questionnaire will result in 8 different scores. A score for perceived susceptability, perceived severity, perceived barrieres, perceived benefits, cues to action, general health motivation, self-efficacy, and a total motivation.
A higher score means more motivation. The scale goes from 'totally do not agree' to 'totally agree'. scores will range between 27 and 135.
Measured: At baseline, after 3 months and after 6 months
Awareness about dementia risk reduction
effectiveness of the website in increasing awareness and knowledge on dementia risk reduction. This is measured by a modified version of the awareness survey that has been used in the 'MijnBreinCoach' study. This questionnaire focuses on knowledge about dementia risk reduction by changing lifestyle factors.
A higher score means more awareness and knowledge on dementia risk reduction. The scale goes from 'totally do not agree' to 'totally agree'. scores will range between 16 and 80.
Measured: At baseline, after 3 months and after 6 months
Secondary outcomes (8)
Change in alcohol consumption
The efficacy of the website in changing a user's consumption of alcohol. This is measured by our questionnaire asking about the consumption of the participant. The change in answers will be an indication that website is successful in changing alcohol consumption.
Measured: At baseline, after 3 months and after 6 months
Change in smoking behaviour
The efficacy of the website in changing a user's smoking behavior. This is measured by our questionnaire asking about the smoking behavior of the participant. The change in answers will be an indication that the website is successful in changing smoking behavior.
Measured: At baseline, after 3 months and after 6 months
Change in physical exercise.
physical activity of a participant is assessed with the Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH). The change in scores/answers will be an indication that the website is effective in changing someone's physical activity.
Measured: At baseline, after 3 months and after 6 months
Change in Diet.
Diet will be assessed with the Mediterranean Diet Adherence Screener (MEDAS). This will assess if the participant follows a Mediterranean diet or not. The change in the score on the MEDAS will indicate if a participant has changed their diet to be more like a Mediterranean diet. This will be an indication that the website is effective in changing a participant's diet.
Scores on the MEDAS questionnaire will range between 0 and 14. A higher score means that the participants follows the mediterranean diet more closely.
Measured: At baseline,after 3 months and after 6 months
Change in Sleep behaviour
Sleep behavior will be assessed by means of the Pitsburg Sleep Quality Index (PSQI). The change in answers on the PSQI will indicate if a participant's sleep pattern and behavior have changed. This will be an indication that the website is effective in changing a participant's sleep behavior.
Measured: At baseline, after 3 months and after 6 months
Change in cognitive activities.
A participant's cognitive activities are assessed with the Cognitive and Leisure Activity Scale (CLAS). A change in this score will indicate if a participant has taken on more or less cognitive activities after using the website. This will be an indication that the website is effective in changing the amount of cognitive activities a participant undertakes.
Answers on the CLAS go from 'never' to 'daily' and the scores will range between 11 and 66. A higher score on the CLAS indicates more cognitive activities for the participants.
Measured: At baseline, after 3 months and after 6 months
Change in Stress levels
Stress is assessed by the Perceived Stress Scale (PSS). A change in scores on the PSS will indicate if a participant feels more or less stressed. This may be an indication that our website is effective in changing the amount of stress a participant feels.
Answers to the PSS questions range from 'never' to 'really often (zeer vaak in dutch)'. The score will range from 10 to 50 and a higher score means the participants has less stress.
Measured: At baseline, after 3 months and after 6 months
Change in Mental health Quality of Life
Quality of life will be assessed using the Mental Health Quality of Life (MHQoL) questionnaire. This questionnaire focuses more on the mental health aspect of quality of life, such as mood, self-image, and feelings toward the future. A change in this score indicates a feeling of a better or worse Quality of life. This may also indicate that our website is effective in changing this feeling.
Questions on the MHQoL have all different answers, they ask about different things such as relations, health and future. The answers are an indication how the participants feels. The score will range between 8 and 32, where a higher score indicates better quality of life.
Measured: At baseline, after 3 months and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start15 Apr 2024
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- mixed-method study with a single-arm pre-post design with a duration of 3 months and extended follow-up after 6 months.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309758
- Sponsor's protocol ID
- 115022
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: plan to share, but no IPD sharing plan ready.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BreinZorg: A Feasibility Study Into an Online Lifestyle Platform for Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD)
- ClinicalTrials.gov ID
- NCT06309758
- Acronym / sponsor ID
- 115022
- Conditions
- Mild Cognitive Impairment, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 13 Mar 2024 (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.
Dementia is the most common disease in older individuals and this century's biggest healthcare challenge. Many patients who visit the memory clinic with memory complaints do not have dementia but instead are diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD). MCI or SCD may be a pre-dementia stage. Many patients with MCI or SCD often leave their consultation with unanswered questions, and unsure what they, themselves can do to reduce dementia risk. Patients with MCI and SCD have a heightened risk of developing dementia. Therefore, this group would possibly benefit most from preventive strategies. Around 40% of dementia cases is attributable to modifiable factors. Thus, managing a healthy lifestyle may reduce dementia risk.
To answer the information request many patients have when leaving the memory clinic and to fill the knowledge gap an online tool has been developed.
The goal of this mixed-method feasibility study is to investigate the usability, feasibility, patient experience, and effectiveness of the personalized, multi-domain online website in older adults with MCI or SCD.
The main questions it aims to answer are:
- Is the new website being used by the target population?
- How does the target population experience the use of the website?
- What is the effect of using the website?
Participants will have access to the website and are free to use the website in any way they want.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- mixed-method study with a single-arm pre-post design with a duration of 3 months and extended follow-up after 6 months.
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: Breinzorg3 month active use of the website. Receive bi-weekly update mails to nudge participants to use the website. |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Visited a memory clinic;
- Recent (no longer than 4 months) diagnosis of MCI or SCD according to the guidelines used in the memory clinic;
- >60 years of age;
- Sufficient fluency in Dutch;
- Internet access at home and a working e-mail address;
Key exclusion criteria (4 listed)
- Diagnosis of Dementia according to the guidelines of the memory clinic;
- Any condition to hinder successful 6-month follow-up;
- Diagnosis of Major depression;
- Coincident participation in any other intervention trial at time of pre-screening.
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 |
|---|---|---|
| BreinzorgThe BreinZorg multidomain lifestyle website comprises 16 domains, namely (1) physical activity, (2) healthy diet, (3) smoking, (4) alcohol, (5) sleep, (6) cognitive activity (7) social activity, (8) diabetes, (9) blood pressure, (10) cholesterol, (11) heart- and vascular diseases, (12) kidney diseases, (13) hearing damage, (14) obesity, (15) anxiety, and (16) depression. These 16 modules are separated into three big themes: mood, lifestyle, and body. Each module consists of the following: 1. General information on the risk factor; 2. Tips on how to improve and decrease the risk; 3. Quiz questions about the risk factor, giving extra knowledge/ in a playful and interactive manner; 4. Examples of SMART goals fitting the risk factor (goal examples are given in a Specific, Measurable, Achievable, Relevant, and Time-Bound manner). | Other | Participants |
Primary outcome
Acceptability of the new online website following the theoretical framework of acceptability
Time frame: After 3 months
The perception among the patients that the intervention (website) is agreeable. The investigators collect data by means of a questionnaire following the theoretical framework of acceptability. Assessing 7 constructs of acceptability: Affective attitude, Burden, Ethicality, Perceived effectiveness, intervention coherence, self-efficacy and, opportunity costs. Additionally, qualitative information is on experiences and acceptability is gathered using semi-structured interviews.
Adoption / Uptake of the new online website. Website usage data.
Time frame: After 3 months and after 6 months
The intention, initial decision, or action to try to employ a new intervention. How much and how is the new website used by the participants? The investigators collect monitoring data of the website on usage of the website.
Demand of the new online website. Website usage data.
Time frame: After 3 months and after 6 months
The estimated use or actual use of the intervention.Monitoring data on the use of the website. How much time do participants spend on the website, which pages do they use and how many times do they visit the website?
Practicality of the new online website.
Time frame: After 3 months
The extent to which the intervention can be delivered. Interviews in a subgroup will contain questions on the burden and barriers of the website. It will also contain questions on the desired frequency, duration, and intensity of the website.
Feeling of trust in yourself and your own abilities.
Time frame: At baseline, after 3 months and after 6 months
Effectiveness of the website in increasing feelings of self-efficacy. This is measured by the General Self-Efficacy Scale (GSES) questionnaire. The scale goes from 'totally do not agree' to 'totally agree'. A higher score on this questionnaire means the participant has more feeling of trust in themselves and their abilities. scores will range between 10 and 50.
Feeling of control about own life and future.
Time frame: At baseline, after 3 months and after 6 months
Effectiveness of the website in increasing feeling of control. This is measured by the 7-item Pearlin Mastery Scale. The scale goes from 'totally do not agree' to 'totally agree'. A higher score on this questionnaire means the participant has more feeling of control. scores will range between 7 and 35.
Motivation to change lifestyle for reduction of dementia risk.
Time frame: At baseline, after 3 months and after 6 months
Effectiveness of the website in increasing motivation to make lifestyle changes. This is measured by the Dutch Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction (MCLHB-DRR) questionnaire. The answers to this questionnaire will result in 8 different scores. A score for perceived susceptability, perceived severity, perceived barrieres, perceived benefits, cues to action, general health motivation, self-efficacy, and a total motivation. A higher score means more motivation. The scale goes from 'totally do not agree' to 'totally agree'. scores will range between 27 and 135.
Awareness about dementia risk reduction
Time frame: At baseline, after 3 months and after 6 months
effectiveness of the website in increasing awareness and knowledge on dementia risk reduction. This is measured by a modified version of the awareness survey that has been used in the 'MijnBreinCoach' study. This questionnaire focuses on knowledge about dementia risk reduction by changing lifestyle factors. A higher score means more awareness and knowledge on dementia risk reduction. The scale goes from 'totally do not agree' to 'totally agree'. scores will range between 16 and 80.
8 secondary outcomes
Change in alcohol consumption
Time frame: At baseline, after 3 months and after 6 months
Change in smoking behaviour
Time frame: At baseline, after 3 months and after 6 months
Change in physical exercise.
Time frame: At baseline, after 3 months and after 6 months
Change in Diet.
Time frame: At baseline,after 3 months and after 6 months
Change in Sleep behaviour
Time frame: At baseline, after 3 months and after 6 months
Change in cognitive activities.
Time frame: At baseline, after 3 months and after 6 months
Change in Stress levels
Time frame: At baseline, after 3 months and after 6 months
Change in Mental health Quality of Life
Time frame: At baseline, after 3 months and after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: Undecided. plan to share, but no IPD sharing plan ready.
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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.
Jurgen Claassen, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breinzorg in people with Mild Cognitive Impairment and Cognitive Decline, run by Radboud University Medical Center at 1 site in Netherlands.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanya Palsma, MSc (024-3639609, tanya.palsma@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the new online website following the theoretical framework of acceptability (time frame: After 3 months). The study lists 8 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 12 Jul 2024.