Condition category
Mental and Behavioural Disorders
Date applied
27/09/2019
Date assigned
07/10/2019
Last edited
02/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Ahead of a large online clinical trial to determine whether reducing blood pressure can prevent dementia, this pilot study will determine the feasibility of recruiting participants aged ≥60 years into an online study. Participants will be recruited via general practice. This study will determine whether participants can complete online registration and consent, measure and enter their home blood pressure online and complete an online cognitive function (thinking and reasoning) questionnaire. This information will inform the design of the larger study. The feasibility of using a portable device to perform study blood tests will be determined by asking participants to attend their GP practice for a blood test using the device (iSTAT).

Who can participate?
Individuals over 60 years old, with a valid email address and access to the internet

What does the study involve?
This is a pilot study to determine the feasibility of performing a large secure online study of blood pressure lowering to prevent dementia, by testing several aspects of trial methodology (including recruitment and baseline data collection).

What are the possible benefits and risks of participating?
Risks- Blood sampling may cause bruising and discomfort. There may be inconvenience to participants attending GP/MEMO research for blood sampling. Online cognitive function questionnaires can take up to 45 minutes to complete. Participants may find asking the alternative contacts to act in this capacity for them in the study uncomfortable.
Benefits- There are no direct benefits however, participants will be able to keep the OMRON home blood pressure monitor.

Where is the study run from?
MEMO Research, Ninewells Hospital, Dundee, UK

When is the study starting and how long is it expected to run for?
November 2019 to May 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof. Thomas MacDonald (scientific),
t.m.macdonald@dundee.ac.uk
Dr Evelien Rooke (public),
e.rooke@dundee.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas MacDonald

ORCID ID

http://orcid.org/0000-0001-5189-6669

Contact details

MEMO Research
Level 7
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0) 1382 383119
t.m.macdonald@dundee.ac.uk

Type

Public

Additional contact

Dr Evelien Rooke

ORCID ID

Contact details

MEMO Research
Level 7
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0) 1382 383119
e.rooke@dundee.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1-020-18

Study information

Scientific title

RECALL – REducing Cognitive decline and dementiA by Lowering bLood pressure - Pilot

Acronym

RECALL

Study hypothesis

Complex interventions aiming to slow cognitive decline have been disappointing, are time-consuming and labour intensive and require extensive commitment on behalf of the health services, individual therapist, and participant. Mounting evidence supports the beneficial effects of reducing blood pressure to ameliorate cognitive decline and to prevent dementia. We intend to conduct a large online study of blood pressure-lowering medication to lower blood pressure and prevent dementia. Although elements of the proposed study methodology have been used in other studies, they have not yet been tested in the target population. We therefore plan a pilot study to assess the feasibility of several aspects of the proposed method.

Ethics approval

Approved 14/05/2019, NHS HRA North East- York Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0) 207 104 8079; nrescommittee.northeast-york@nhs.net), ref: 19/NE/0172

Study design

Feasibility study

Primary study design

Other

Secondary study design

Trial setting

Internet

Trial type

Other

Patient information sheet

Not available in web format. Please use contact details to request a participant information sheet

Condition

Cognitive decline

Intervention

Potential participants will be invited to visit a study web page by letter of invitation. On this study webpage they can read the participant information documentation and then complete an electronic informed consent form. Participants will then be asked to complete questions on their demographics, medical history, and lifestyle. Consenting participants will be supplied with a home blood pressure monitor (HBPM) and detailed instructions on how to use it. They will then be asked to submit a set of readings (modified version of NICE guidance) to the website. Following consent participants will be asked to complete an online cognitive function assessment hosted by Cambridge Brain Sciences (CANADA) and attend either their GP or the MEMO Research Unit in Dundee to have a blood sample taken. They will also be asked to provide two alternative contact details. The participant will be asked to get the permission of their alternative contacts before entering their details into the RECALL secure website. The alternative contacts will be asked by email if they are willing to act in this capacity.
Once this information has been submitted the participants will be asked to complete feedback questionnaires on the study/website. All aspects of the study are voluntary and so the participants may still proceed to the next section whether they have completed the previous section of the study or not. Once the participant has submitted their information then their participation is the study is complete. Participants will be asked to complete the tasks within 4 weeks if possible. There will be no follow up.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Recruitment numbers
2. Protocol adherence
Timepoint: End of pilot

Secondary outcome measures

1. Assess suitability of online cognitive testing for study cohort
Outcome measures: Proportion of participants who complete a baseline test
2. Assess baseline cognitive function
Outcomes measures: Proportion of study population completing online screening cognitive function test, and scores obtained
3. Assess feasibility of requiring each participant to identify two individuals who agree to act as alternative contacts
Outcome measures: Proportion of participants who have two consenting alternative contacts
4. Assess feasibility of home blood pressure monitoring using study supplied HBPM machine
Outcome measures: Proportion of participants submitting a complete set of home BP measurements
5. Assess baseline blood pressure suitability of study cohort
Outcome measures: Proportion of participants with a home BP submission averaging 140mmHg or below systolic
6. Assess feasibility of using portable i-STAT Alinity device for providing blood results
Outcome measures: Proportion of blood results obtained using portable system
7. Assess the likely number of eligible patients signing up
Outcome measures: Proportion of those invited who meet proposed formal study entry criteria

Overall trial start date

14/10/2019

Overall trial end date

13/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 60 years old
2. Valid email address (per participant)
3. Able to access the internet

Participant type

Other

Age group

Senior

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. GPs may exclude participants who they deem unsuitable to participate
2. Clinical diagnosis of dementia, treatment with medication for dementia or cognitively unable to follow the protocol (investigator opinion)

Recruitment start date

01/11/2019

Recruitment end date

01/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MEMO Research
Level 7 Mailbox 2 Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee/NHS Tayside

Sponsor details

TASC (Tayside Medical Science Centre)
University of Dundee
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0) 1382 383900
TASCgovernance@dundee.ac.uk

Sponsor type

University/education

Website

http://www.ahspartnership.org.uk/ahsp

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Protocol to be published in BMJ Open. Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

30/09/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/10/2019: Trial’s existence confirmed by NHS HRA North East- York Research Ethics Committee