|- candidate number||14812|
|- NTR Number||NTR3973|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-apr-2013|
|- Secondary IDs||NL43649.068.13 METC Azm/UM|
|- Public Title||Online intervention program ‘Houd uw brein vitaal’.|
|- Scientific Title||‘The effectiveness of an online cognitive intervention program (‘Houd uw brein vitaal’) in healthy adults, a randomized controlled trial’.|
|- hypothesis||The primary objective of this study is to investigate the effectiveness of an online cognitive intervention program. It is investigated whether participants subjective cognitive functioning, objective cognitive functioning and psychological wellbeing is influenced by participating in an online intervention program. |
|- Healt Condition(s) or Problem(s) studied||Cognitive problems, Forgetfulness, Memory problems|
|- Inclusion criteria||1. Signed informed consent;|
2. Age between 40 and 65 years old;
3. Adequate comprehension of the Dutch language;
4. Availability of desktop or laptop computer.
|- Exclusion criteria||1. History of chronic neurological or neurodegenerative disorders (e.g. stroke or dementia);|
2. Abuse of alcohol and/or drugs.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2013|
|- planned closingdate||31-dec-2013|
|- Target number of participants||300|
|- Interventions||Participants are randomly assigned to one of two groups; group A (experimental group) or group B (waiting-list control group) and are invited to do the baseline measurements (T0). Participants in group A get access to the intervention program immediately after finishing the baseline measurements. After finishing the program they are invited to do the post-test measurements (T1) and 4 weeks later the follow up measurements (T2). Participants in group B get access to the internet program after accomplishing the second (T1) and third measurements (T2).
The online intervention program is a multidimensional program focusing on increasing awareness of the age-related changing brain, giving insight into personal improvements and providing tips and strategies regarding memory, attention and planning. The intervention consist of 3 educational modules:
1. A lifestyle module in which (lifestyle) factors influencing cognitive functioning are discussed. Only evidence-based influential factors are included;
2. A memory module in which the cause of memory complaints, memory self-efficacy and memory strategies are discussed;
3. An effective work module in which tips for improving attention and planning skills are presented to the participants.
Each module incorporates information provided in text or short video-messages and (homework) exercises.
The duration of the online intervention is depending on the speed at which the participant completes the online intervention modules, but a maximum of 4 weeks is allowed. The estimated time to complete each intervention module (including the exercises) is between 2 and 2,5 hours per module.
|- Primary outcome||Subjective cognitive functioning measured with:|
1. Metamemory in Adulthood questionnaire (MIA);
2. Cognitive Failures Questionnaire (CFQ);
3. Perceived degree of hinder, worry and annoyance about subjective memory functioning and subjective executive functioning;
4. Evaluation questions regarding the intervention and self evaluation after participation.
|- Secondary outcome||Psychological Well-being measured with:|
1. Depression Anxiety Stress Scale (DASS);
2. Satisfaction with life scale (SWLS);
4. Loneliness Questionnaire (LQ);
5. Need for recovery (NFR);
6. Short form-12 health survey (SF-12).
Objective cognitive functioning measured with:
1. Word learning test;
2. Trail making test;
3. Letter Digit substition test.
|- Timepoints||Pretest (baseline): All primary and secondary measures;|
Post-test 1, 4 weeks after pretest: All primary and secondary measures;
Post-test 2, 8 weeks after pretest: Primary measures.
|- Trial web site||www.BreinWeb.nl|
|- CONTACT FOR PUBLIC QUERIES||Dr. Jennifer Reijnders|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Martin Boxtel, van|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|National Initiative Brain & Cognition (NIHC), Netherlands Organisation for Scientific Research (NWO)|
|- Brief summary||As people age, they increasingly encounter difficulties regarding changes in cognitive abilities. This is reinforced by the increase in productivity and the great appeal on intellectual abilities in many work tasks. Intervention programs focusing on coping with age-related cognitive changes and increasing memory self-efficacy could be an important and effective tool to counteract age-related psychological distress. |
The primary objective of this study is to investigate the effectiveness of an online cognitive intervention program ('Houd uw brein vitaal') for healthy adults between 40 and 65 years old. It is investigated whether participants subjective cognitive functioning (memory self-efficacy, self evaluation, and everyday mistakes), objective cognitive functioning (measured with 3 different cognitive tasks) and psychological wellbeing (measured with questionnaires) is influenced by participating in an online intervention program.
The online intervention program is a multidimensional program focusing on increasing awareness of the age-related changing brain, giving insight into personal improvements and providing tips and strategies regarding memory, attention and planning. The intervention consist of 3 educational modules; lifestyle, memory and effective work. Each module incorporates information provided in text or short video-messages and (homework) exercises. The duration of the online intervention is dependent on the speed of the participants but will be approximately 2 hours per module.
|- Main changes (audit trail)|
|- RECORD||26-apr-2013 - 28-mei-2013|