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

NCT06309758 | Unknown

• 1 other identifier: 115022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Cognitive Decline

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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?

  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.

  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.

  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.

  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.

  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.

  At baseline, after 3 months and after 6 months

Secondary Outcomes (8)

• Change in alcohol consumption

  At baseline, after 3 months and after 6 months

• Change in smoking behaviour

  At baseline, after 3 months and after 6 months

• Change in physical exercise.

  At baseline, after 3 months and after 6 months

• Change in Diet.

  At baseline,after 3 months and after 6 months

• Change in Sleep behaviour

  At baseline, after 3 months and after 6 months

Study Arms (1)

Participants

EXPERIMENTAL

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

Other: Breinzorg

Interventions

Breinzorg 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).

Participants

Eligibility Criteria

• Age: 61 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Tanya Palsma, MSc

CONTACT

024-3639609; tanya.palsma@radboudumc.nl

Jurgen Claassen, Dr.

CONTACT

jurgen.Claassen@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: mixed-method study with a single-arm pre-post design with a duration of 3 months and extended follow-up after 6 months.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 13, 2024
• Study Start: April 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-01

Locations

NL (1)