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
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
Contact information
Scientific
MEMO Research
Level 7
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0001-5189-6669 |
|---|---|
| Phone | +44 (0) 1382 383119 |
| t.m.macdonald@dundee.ac.uk |
Public
MEMO Research
Level 7
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0) 1382 383119 |
|---|---|
| e.rooke@dundee.ac.uk |
Study information
| Study design | Feasibility study |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | Internet/virtual |
| Study type | Other |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | RECALL – REducing Cognitive decline and dementiA by Lowering bLood pressure - Pilot I |
| Study acronym | RECALL |
| Study objectives | 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(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) studied | 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, 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 type | Other |
| 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 study start date | 14/10/2019 |
| Completion date | 18/06/2021 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 110 |
| Total final enrolment | 251 |
| Key inclusion criteria | 1. Over 60 years old 2. Valid email address (per participant) 3. Able to access the internet |
| Key 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) |
| Date of first enrolment | 01/11/2019 |
| Date of final enrolment | 20/05/2021 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Mailbox 2
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Sponsor information
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 |
|---|---|
| TASCgovernance@dundee.ac.uk | |
| Website | http://www.ahspartnership.org.uk/ahsp |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Protocol to be published in BMJ Open. Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The 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
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
