Clinical trial NCT06309758: BreinZorg: Feasibility Study Into an Online Lifestyle Platform for MCI and SCD
Official title: BreinZorg: A Feasibility Study Into an Online Lifestyle Platform for Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Cognitive Decline
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief 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). 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of the new online website following the theoretical framework of acceptability
timeFrame: After 3 months
measure: Adoption / Uptake of the new online website. Website usage data.
timeFrame: After 3 months and after 6 months
measure: Demand of the new online website. Website usage data.
timeFrame: After 3 months and after 6 months
measure: Practicality of the new online website.
timeFrame: After 3 months
measure: Feeling of trust in yourself and your own abilities.
timeFrame: At baseline, after 3 months and after 6 months
measure: Feeling of control about own life and future.
timeFrame: At baseline, after 3 months and after 6 months
measure: Motivation to change lifestyle for reduction of dementia risk.
timeFrame: At baseline, after 3 months and after 6 months
measure: Awareness about dementia risk reduction
timeFrame: At baseline, after 3 months and after 6 months
Secondary outcomes:
measure: Change in alcohol consumption
timeFrame: At baseline, after 3 months and after 6 months
measure: Change in smoking behaviour
timeFrame: At baseline, after 3 months and after 6 months
measure: Change in physical exercise.
timeFrame: At baseline, after 3 months and after 6 months
measure: Change in Diet.
timeFrame: At baseline,after 3 months and after 6 months
measure: Change in Sleep behaviour
timeFrame: At baseline, after 3 months and after 6 months
measure: Change in cognitive activities.
timeFrame: At baseline, after 3 months and after 6 months
measure: Change in Stress levels
timeFrame: At baseline, after 3 months and after 6 months
measure: Change in Mental health Quality of Life
timeFrame: At baseline, after 3 months and after 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
References: