Condition category
Mental and Behavioural Disorders
Date applied
06/01/2017
Date assigned
11/01/2017
Last edited
03/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Prospective memory (PM) is a form of memory which involved remembering to perform intended actions in the future, simply, remembering to remember. It is an important function and is necessary in order for people to be able to live independently and be self-sufficient. Examples of prospective memory include: remembering to take medicine at night before going to bed, or remembering to go to an appointment. PM can be divided into three types; time-based, event-based, and activity-based. Time-based PM involves remembering to perform an action at a specific time or after a period of time. Event-based PM involves remembering to perform an intention when a cue (reminder) appears. Activity-based PM involves remembering to perform an intention upon the completion of an activity. Maintaining PM is very important for the elderly to be able to live independently. Forgetting things that they need to remember can be upsetting for some older adults, leading to mental health problems such as anxiety and depression. The aim of this study is to find out whether a short program designed to help exercise PM functions can lead to improvements in PM and mood in older adults.

Who can participate?
Adults aged 60 and over who are educated to at least secondary education level

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in a program designed to improve their prospective memory. This involves taking part in one two-hour session each week for a total of six weeks, where participants play a computerised board game designed to exercise their prospective memory as well as taking part in a memory strategy training. Those in the second group receive no extra training and continue as normal for the duration of the study. At the start of the study and then again after six and ten weeks, participants in both groups undergo a number of assessments to assess their prospective memory and mental wellbeing.

What are the possible benefits and risks of participating?
Participants may benefit from improvements to their prospective memory and mental wellbeing. There are no notable risks involved with participating in this study.

Where is the study run from?
University of the Third Age (Malaysia)

When is the study starting and how long is it expected to run for?
February 2016 to July 2017

Who is funding the study?
Universiti Putra Malaysia (Malaysia)

Who is the main contact?
Ms Azin Farzin
aizan@upm.edu.my

Trial website

Contact information

Type

Public

Primary contact

Ms Azin Farzin

ORCID ID

http://orcid.org/0000-0001-6104-4670

Contact details

Malaysian Institute on aging (Myageing)/Institute of Gerontology
University Putra Malaysia
Serdang
43400
Malaysia
+60 1 128 059 793
aizan@upm.edu.my

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IG(EXP16)P115

Study information

Scientific title

Evaluation of a preventative multi-disciplinary training program for prospective memory among older adults: A randomized controlled trial

Acronym

Study hypothesis

There is a significant improvement in prospective memory functions among older adults following a 12-hour multi-component cognitive-based intervention.

Ethics approval

Ethical Committee of University Putra Malaysia, 07/12/2016, ref: IG[EXP16]P115

Study design

Single-centre single-blinded randomised cross over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Memory function

Intervention

Participants will be randomly assigned to the intervention or control groups (1:1) in site-specific blocks that vary randomly in size to ensure adequate randomization, developed by http://www.randomization.net. The randomization sequence will be concealed from research staff.

Intervention group: Participants take part in a 12 hour intervention regarding exercising their prospective memory. This involves one two-hour session per week for six weeks, and involves a process-based intervention component (a computerized board game to exercise prospective memory - VIRTUAL WEEK board game) and a strategy-based intervention component (memory strategy training such as; intention implementation intentions).

Control group: Participants receive no additional treatment and continue as normal for the duration of the study.

Follow up takes place after six week, one month later (10 weeks) and three months later (14 weeks) and involves prospective memory, depression, anxiety and instrumental daily living activities assessments.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Prospective memory (PM) functions are assessed at baseline, 6, 10 and 14 weeks using:
1. PM functions (time-, event-, and activity-based PM) are assessed using a computer-based test
2. PRMQ (a paper-pencil questionnaire) to be used as a subjective measure for PM functions

Secondary outcome measures

1. Instrumental daily living activities are measured using the Instrumental Activities of Daily Living Scale at baseline, 6, 10 and 14 weeks
2. Depression is measured using the Geriatric Depression Scale (GDS) at baseline, 6, 10 and 14 weeks
3. Anxiety is measured using the Geriatric Depression Scale (GDS) at baseline, 6, 10 and 14 weeks

Overall trial start date

01/02/2016

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 60 years and above
2. Educational level of at least secondary educational level

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

42 participants for each arm (84 participants in total)

Participant exclusion criteria

1. Aged less than 60 years old
2. Are not educated enough or are illiterate
3. Those who do not show normal cognitive functions
4. Suffering from a psychological or learning disability
5. History of nuerological impairments (measured by MMSE)
6. Any major psychiatric disorders (taking any psychoactive medication (e.g., anti-depressive, anxiolytics)) and learning disabilities
7. History of general anaesthesia, head truamas (in the last 6 months prior to the study), cerbrovascular disease, or neurological impairments
8. Drug/alcohol abuse

Recruitment start date

01/05/2016

Recruitment end date

28/01/2017

Locations

Countries of recruitment

Malaysia

Trial participating centre

U3A (University of the Third Age)
Universiti Putra Malaysia Selangor Darul Ehsan
Serdang
43400
Malaysia

Sponsor information

Organisation

Universiti Putra Malaysia

Sponsor details

Jalan Upm
Serdang
43400
Malaysia

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Universiti Putra Malaysia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rahimah binti Ibrahim (imahibrahim@upm.edu.my)

Intention to publish date

30/09/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/11/2017: The overall trial end date has been updated from 20/12/2017 to 30/09/2018. 04/08/2017: Study design has been updated from a randomised controlled trial to a randomised cross over trial. 19/06/2017: The overall trial end date has been updated from 20/07/2017 to 20/12/2017 and the recruitment end date has been updated from 01/07/2016 to 28/01/2017. In addition, an additional follow up timepoint of three months has been added.