Condition category
Mental and Behavioural Disorders
Date applied
20/02/2018
Date assigned
22/02/2018
Last edited
22/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
As we age, we may experience general declines in our thinking, memory and reasoning skills (cognitive ageing). There is, however, large variation in the degree of decline experienced. Keeping intellectually, socially or physically engaged have all been proposed as potentially protective. These factors have been incorporated in interventions for cognitive ageing, though are often developed and tested in lab-based settings that may not translate to realistic environments. This study tests a range of activities within existing community-based programmes as potential interventions to reduce cognitive ageing in old age. The activities selected vary in their social, intellectual or physical demands, so the key question relates to how these different aspects of engagement might relate to benefits across different types of thinking skills.

Who can participate?
People aged 65 and over in Edinburgh and the Lothians (Scotland).

What does the study involve?
Participants attend two screening visits. During their first visit, participants complete some assessments of memory, attention and other cognitive functions. Participants also complete some questionnaires related to their background, current health and well-being, and some physical tests that measure blood pressure, grip strength and lung capacity. A saliva sample are also collected. The saliva sample is tested for different genes later on. The saliva sample stored for gene testing are kept completely anonymous as these tests are of no importance for your health as an individual. Participants are then randomly allocated into one of six activities that could be any of the following: computer classes, participation in social clubs, bingo, exercise or sport classes, gardening, dance or drama groups, musical instrument or language classes, and woodcraft. Participants need to be randomly assigned to each group to ensure that any changes observed as a result of taking up a new activity are not because of initial differences between participants. The activity duration will be around 2 hours per week and will run for between 10-12 weeks. Participants return for another testing session and are asked repeat the cognitive and health measures taken at the first session. After completing this second assessment, you will be given the opportunity to complete a second new activity, or return to complete some further tests after about 3 months. You do not need to decide on that just now as you’ll be given fuller details at the time.

What are the possible benefits and risks of participating?
Participants may or may not get a direct benefit from taking part in this study though all participants will attend a new activity free of charge. The outcomes of the study will, however, help to better understand how taking up new activities might benefit thinking skills. It is not thought that there are many disadvantages. It is highly unlikely that participation in this study will cause participants to become bored, tired or distressed; however, if this happens, participants can stop at any time. If participants become distressed for any reason, they may discuss this with any of the researchers.

Where is the study run from?
This study is being organised The Ageing Lab at Heriot-Watt University (UK).

When is the study starting and how long is it expected to run for?
June 2017 to December 2019.

Who is the main contact?
Dr Alan Gow (A.J.Gow@hw.ac.uk).

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alan Gow

ORCID ID

http://orcid.org/0000-0002-3320-4531

Contact details

Department of Psychology
School of Social Sciences
Heriot-Watt University
Edinburgh
EH14 4AS
United Kingdom

Type

Public

Additional contact

Dr Eleftheria Vaportzis

ORCID ID

Contact details

Department of Psychology
School of Social Sciences
Heriot-Watt University
Edinburgh
EH14 4AS
United Kingdom
+44 131 451 8009
HealthyAgeing@hw.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1034

Study information

Scientific title

The Intervention Factory: Advancing community-based activities as interventions for cognitive ageing

Acronym

Study hypothesis

Primary study objective: To develop and test the efficacy of a series of real-world activities as potential interventions to reduce or delay cognitive ageing. Specifically, examination of the effects of interventions on cognitive ability at both general and domain-specific levels (memory, processing speed, reasoning), exploring whether different intervention types have different effects.

Ethics approval

1. School of Social Sciences Ethics Committee, Heriot-Watt University, 12/05/2017, ref: 2017-453
1. South East Scotland NHS Research Ethics Committee, 22/12/2017, ref: REC reference number: 17/SS/0153, SSA reference number: 17/SS/0157, IRAS project ID: 238302

Study design

Single-centre interventional randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

https://healthyageing.hw.ac.uk/images/downloads/IF_Information_Sheet-December_2017_Version_2-18_December_2017.pdf

Condition

Cognitive ageing

Intervention

Participants meet with a researcher at Heriot-Watt University on two occasions. During their first visit, participants complete some assessments of memory, attention and other cognitive functions. Participants also complete some questionnaires related to their background, current health and well-being, and some physical tests that measure blood pressure, grip strength and lung capacity. A saliva sample are also collected. The saliva sample is tested for different genes later on. The saliva sample stored for gene testing are kept completely anonymous as these tests are of no importance for your health as an individual. The researcher explains each assessment, and are able to ask any questions as you go along. The testing sessions last about 2.5 hours, and there are time for breaks.

On completion of their baseline assessments, participants are randomised to one of six intervention groups: language classes, social groups, handicraft/woodcraft classes, bingo, exercise classes and computer classes. All interventions run for 10-12 weeks and all are based within existing community-based settings.

All interventions are community classes that run in Edinburgh and surrounding areas. The research team is not involved in the interventions (these are for example, classes run by Adult Education or similar organisations). Participants attend these groups as if they were regular attendees; the classes are not constituted for the purposes of the study. Participants are assigned to one of the six activity groups after their baseline assessments, which must constitute a new activity for them. After completing their new activity for ~10-12 weeks, participants return for follow-up assessments.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Cognitive ability is measured using the Mini-Mental State Examination, the Clock Drawing Task, psychometric tests (from the Wechsler Adult Intelligence Test (WAIS)-IV, Wechsler Memory Scale (WMS)-IV at baseline and three months.

The main analyses will be mixed model analysis of variance. Briefly, the cognitive domain scores will be computed as described in the WAIS-IV and WMS-IV manuals. To investigate the effect of the interventions on cognitive performance, 6 x 2 mixed model ANOVA will be conducted with the between factor Group (five intervention groups and the placebo control) and within factor Time (pre-test, post-test) for each of the cognitive ability domains separately.

Secondary outcome measures

1. Mental wellbeing is measured using the Warwick-Edinburgh Mental Wellbeing Scale at baseline and three months.
2. Quality of life is measured using the WHO Quality of Life Scale at baseline and three months.
3. Anxiety and depression are measured using the Hospital Anxiety and Depression Scale at baseline and three months.
4. Physical function is measured at baseline and three months, comprising: blood pressure is measured using a digital sphygmomanometer; lung function is measured using a spirometer; grip strength is measured using a handheld dynamometer; balance, chair stands and walk speed are measure using the Short Portable Physical Performance Battery.

Overall trial start date

12/05/2017

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 65 or over
2. Resident in Edinburgh or the Lothians

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Younger that 65 years old
2. Not resident in Edinburgh or the Lothians
3. Diagnosed with a memory/cognitive impairment or dementia

Recruitment start date

01/06/2017

Recruitment end date

01/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Heriot-Watt University
Department of Psychology School of Social Sciences
Edinburgh
EH14 4AS
United Kingdom

Sponsor information

Organisation

Heriot-Watt University

Sponsor details

Heriot-Watt University
Edinburgh
EH14 4AS
United Kingdom
+44 131 451 3070
res@hw.ac.uk

Sponsor type

University/education

Website

www.hw.ac.uk

Funders

Funder type

Charity

Funder name

Velux Stiftung

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, not anticipated before 31/12/2019, in addition to inclusion in a PhD thesis due for submission 31/08/2020. The first publication will comprise an empirical paper describing the main cognitive intervention findings; additional publications linked to the PhD thesis will comprise comparison of benefits according to age group, baseline cognitive status, and personality characteristics.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Dr Alan Gow (A.J.Gow@hw.ac.uk), as raw or computed data in anonymised format for the purposes of scrutiny of published results or agreed new analyses. Participants consent to data being retained for future analyses coordinated by the research team, but not for these to be uploaded to a public repository; all requests for data will be via the Principal Investigator Dr Alan Gow.

Intention to publish date

31/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes