Evaluation of a preventative multi-disciplinary training program for prospective memory among older adults
| ISRCTN | ISRCTN57600070 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57600070 |
| Secondary identifying numbers | IG(EXP16)P115 |
- Submission date
- 06/01/2017
- Registration date
- 11/01/2017
- Last edited
- 11/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
Malaysian Institute on aging (Myageing)/Institute of Gerontology
University Putra Malaysia
Serdang
43400
Malaysia
 ORCID ID |
0000-0001-6104-4670 |
|---|---|
| Phone | +60 (0)1 128 059 793 |
| aizan@upm.edu.my |
Study information
| Study design | Single-centre single-blinded randomised cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Evaluation of a preventative multi-disciplinary training program for prospective memory among older adults: a randomized controlled trial |
| Study objectives | There is a significant improvement in prospective memory functions among older adults following a 12-hour multi-component cognitive-based intervention. |
| Ethics approval(s) | Ethical Committee of University Putra Malaysia, 07/12/2016, ref: IG[EXP16]P115 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2016 |
| Completion date | 30/09/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 42 participants for each arm (84 participants in total) |
| Total final enrolment | 25 |
| Key inclusion criteria | 1. Aged 60 years and above 2. Educational level of at least secondary educational level |
| Key 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 |
| Date of first enrolment | 01/05/2016 |
| Date of final enrolment | 28/01/2017 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Selangor Darul Ehsan
Serdang
43400
Malaysia
Sponsor information
University/education
Jalan Upm
Serdang
43400
Malaysia
"ROR" |
https://ror.org/02e91jd64 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2018 | Yes | No | |
| Results article | 22/04/2021 | 11/05/2021 | Yes | No |
Editorial Notes
11/05/2021: Publication reference and total final enrolment added.
03/04/2018: Publication reference added.
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.
