BreinZorg: Feasibility Study Into an Online Lifestyle Platform for MCI and SCD

NCT ID: NCT06309758

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2025-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment Cognitive Decline

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

mixed-method study with a single-arm pre-post design with a duration of 3 months and extended follow-up after 6 months.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants

3 month active use of the website. Receive bi-weekly update mails to nudge participants to use the website.

Group Type EXPERIMENTAL

Breinzorg

Intervention Type OTHER

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:

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Breinzorg

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:

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Radboud university medical center

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tanya Palsma, MSc

Role: CONTACT

024-3639609

Jurgen Claassen, Dr.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tanya Palsma, MSc

Role: primary

0243639609

Jurgen Claassen, Dr.

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

115022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Motoric Cognitive Risk and Depression
NCT03679221 ACTIVE_NOT_RECRUITING