Reducing cognitive decline and dementia by lowering blood pressure pilot I study

ISRCTN ISRCTN43958304
DOI https://doi.org/10.1186/ISRCTN43958304
Secondary identifying numbers 1-020-18
Submission date
27/09/2019
Registration date
07/10/2019
Last edited
31/03/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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/Community Hubs 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 June 2021

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

Study website

Contact information

Prof Thomas MacDonald
Scientific

MEMO Research
Level 7
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

ORCiD logoORCID ID 0000-0001-5189-6669
Phone +44 (0) 1382 383119
Email t.m.macdonald@dundee.ac.uk
Dr Evelien Rooke
Public

MEMO Research
Level 7
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Phone +44 (0) 1382 383119
Email e.rooke@dundee.ac.uk

Study information

Study designFeasibility study
Primary study designOther
Secondary study design
Study setting(s)Internet/virtual
Study typeOther
Participant information sheet Not available in web format. Please use contact details to request a participant information sheet
Scientific titleRECALL – REducing Cognitive decline and dementiA by Lowering bLood pressure - Pilot I
Study acronymRECALL
Study objectivesComplex 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(s)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
Health condition(s) or problem(s) studiedCognitive decline
InterventionPotential 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, the MEMO Research Unit in Dundee or Community Hubs 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 typeOther
Primary outcome measure1. Recruitment numbers
2. Protocol adherence
Timepoint: End of pilot
Secondary outcome measures1. 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 study start date14/10/2019
Completion date18/06/2021

Eligibility

Participant type(s)Other
Age groupSenior
SexBoth
Target number of participants110
Total final enrolment251
Key inclusion criteria1. Over 60 years old
2. Valid email address (per participant)
3. Able to access the internet
Key exclusion criteria1. 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)
Date of first enrolment01/11/2019
Date of final enrolment20/05/2021

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

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

Sponsor information

University of Dundee/NHS Tayside
University/education

TASC (Tayside Medical Science Centre)
University of Dundee
Ninewells Hospital & Medical School
Dundee
DD1 9SY
Scotland
United Kingdom

Phone +44 (0) 1382 383900
Email TASCgovernance@dundee.ac.uk
Website http://www.ahspartnership.org.uk/ahsp
ROR logo "ROR" https://ror.org/03h2bxq36

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planProtocol to be published in BMJ Open. Planned publication in a high-impact peer-reviewed journal.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 5 26/04/2021 12/08/2022 No No
Statistical Analysis Plan version 1 14/07/2021 12/08/2022 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN43958304 _Protocol_V5_26Apr2021.pdf
ISRCTN43958304_SAP_V1_14Jul2021.pdf

Editorial Notes

31/03/2023: The intention to publish date has been changed from 28/02/2023 to 31/12/2023.
30/08/2022: The intention to publish date has been changed from 30/06/2022 to 28/02/2023.
12/08/2022: Protocol and SAP files uploaded.
14/12/2021: The intention to publish date was changed from 31/12/2021 to 30/06/2022.
16/06/2021: The total final enrolment number has been added.
19/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/05/2020 to 20/05/2021.
2. The overall trial end date was changed from 13/05/2021 to 18/06/2021.
3. The intention to publish date was changed from 30/09/2021 to 31/12/2021.
12/06/2020: The intention to publish date was changed from 30/09/2020 to 30/09/2021.
11/06/2020: The following changes were made to the trial record:
1. Due to current public health guidance, recruitment for this study has been paused.
2. The overall trial end date was changed from 13/05/2020 to 13/05/2021.
29/01/2020: The following changes have been made:
1. The trial website has been added.
2. The public title has been changed from "Reducing cognitive decline and dementia by lowering blood pressure pilot study to Reducing cognitive decline and dementia by lowering blood pressure pilot I study".
3. The scientific title has been changed from "RECALL – REducing Cognitive decline and dementiA by Lowering bLood pressure - Pilot" to "RECALL – REducing Cognitive decline and dementiA by Lowering bLood pressure - Pilot I".
02/10/2019: Trial’s existence confirmed by NHS HRA North East- York Research Ethics Committee