43958304 true RECALL – REducing Cognitive decline and dementiA by Lowering bLood pressure - Pilot I RECALL 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. 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 1. Recruitment numbers 2. Protocol adherence Timepoint: End of pilot 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 Old ethics approval format 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 10.1186/ISRCTN43958304 1-020-18 1-020-18 Feasibility study Other Not applicable Other 2021-06-18T00:00:00.000Z United Kingdom Scotland MEMO Research

Level 7 Mailbox 2 Ninewells Hospital

Dundee Scotland DD1 9SY Other 1. Over 60 years old 2. Valid email address (per participant) 3. Able to access the internet Senior All 110 251 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) 2019-11-01T00:00:00.000Z 2021-05-20T00:00:00.000Z Cognitive decline Mental and Behavioural Disorders Cognitive decline 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. Other Data sharing statement to be made available at a later date Thesis results in https://discovery.dundee.ac.uk/ws/portalfiles/portal/108320793/Evelien_Rooke_MD_Thesis-Final.pdf (added 26/05/2026) Results

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Study website Migrated from study website field

8b764b52-0933-452c-b3fc-cc3a563177de c774828d-6e48-4368-bf4e-1081ddbe2fd4 38026e2d-fefd-4558-8aca-01626eed4605 6a96d246-8b66-4cb7-8af7-309885d13f2c No Protocol file ISRCTN43958304 _Protocol_V5_26Apr2021.pdf 5d052497-b5a8-49f0-b415-60e0047b474d true application/pdf 434341 7cb756cba8af04e1a8d7faab00ddbb46 Statistical Analysis Plan ISRCTN43958304_SAP_V1_14Jul2021.pdf 8b140689-0982-4095-a653-105e79176590 true application/pdf 353859 dbe6ffaf0d0cd1ec4530ef6212d051b2 Thomas MacDonald https://orcid.org/0000-0001-5189-6669 Scientific

MEMO Research Level 7 Ninewells Hospital & Medical School

Dundee United Kingdom DD1 9SY +44 (0) 1382 383119 t.m.macdonald@dundee.ac.uk Public Evelien Rooke Public

MEMO Research Level 7 Ninewells Hospital & Medical School

Dundee United Kingdom DD1 9SY +44 (0) 1382 383119 e.rooke@dundee.ac.uk Public University of Dundee/NHS Tayside University/education https://ror.org/03h2bxq36 Non-commercial Investigator initiated and funded 07695192 true Reducing binge drinking among disadvantaged men through an intervention delivered by mobile phone: a multi-centre randomised controlled trial TRAM A brief alcohol intervention delivered by mobile phone will reduce binge drinking among disadvantaged young to middle-aged men. Background and study aims Alcohol-related problems represent a major public health challenge. People who are socially disadvantaged are at a substantially higher risk of developing alcohol-related diseases. The group who drink most alcohol and binge drink most frequently are young to middle aged disadvantaged men. There is a pressing need to change the culture of drinking among this group in order to prevent alcohol-related problems in later life. The main objective of this study is to determine whether a brief intervention delivered by mobile phone is an effective and cost-effective method of reducing the frequency of binge drinking by disadvantaged men. The impact of the intervention on other measures of drinking, such as total consumption, will also be assessed. Who can participate? Men aged 25-44 years living in areas of high deprivation will be recruited. Men will be included in the study if they have had two or more episodes of heavy drinking (more than eight units in a single session) in the preceding month. What does the study involve? Men will be recruited to the study by two methods: by letter of invitation from their own GP; and through a community outreach approach where men will be recruited from a variety of venues and work-places within the community. Participants will be randomly allocated to one of two groups. Both groups will receive a series of text messages delivered by mobile phone over a period of three months. Messages sent to the intervention group are designed to help the men to realise that they are at risk from their drinking and motivate them to change their drinking behaviour. The messages will help to increase their self-confidence to refuse drinks, encourage them to make a commitment to drinking less and support them to continue a pattern of reduced binge drinking. The control group will receive text messages on general health promotion. Participants will be followed up at three months and twelve months after the intervention has been delivered. The men will be asked to complete questionnaires by telephone interview. What are the possible benefits and risks of participating? The potential benefits are that participants will reduce their frequency of binge drinking. Participants in the intervention group will receive specific information about reducing alcohol consumption and strategies to for relapse prevention, so that they may achieve sustained behaviour change.No potential risks have been identified. The intervention is based on Alcohol Brief Interventions (ABI) to reduce alcohol consumption which have been extensively used in health care settings and have been shown to be effective in reducing consumption. Where is the study run from? The study is being run from the University of Dundee. Collaborators are also based at the Universities of Aberdeen, Glasgow Caledonian, Newcastle, St Andrews and Stirling in the UK and Melbourne, Australia. Participants will be recruited at four centres which cover major regions of Scotland, UK: Tayside, Glasgow, Forth Valley and Fife. When is the study starting and how long is it expected to run for? The study started in July 2013 and will run for three years and three months. Recruitment of participants will begin in March 2014 and will last for ten months. Who is funding the study? The study is funded by the NIHR Public Health Research Programme, UK. Who is the main contact? Professor Iain Crombie i.k.crombie@dundee.ac.uk The proportion of men consuming more than 8 units of alcohol on at least three occasions in the previous 30 days, one year after the intervention has been delivered 1. The proportion of men consuming more than 8 units of alcohol on at least three occasions in the previous 30 days, three months after the intervention has been delivered. 2. The proportion of men consuming more than 16 units in a single session in the previous 30 days, three months after the intervention has been delivered. 3. The proportion of men consuming more than 16 units in a single session in the previous 30 days, twelve months after the intervention has been delivered. 4. The proportion of men drinking hazardously [measured by the Fast Alcohol Screening Test (FAST)], twelve months after the intervention has been delivered. 5. Total alcohol consumption (units in the previous 30 days), twelve months after the intervention has been delivered. Old ethics approval format East of Scotland Research Ethics Service (EoSRES) REC 1, 18/06/2013, ref: 13/ES0058 10.1186/ISRCTN07695192 PHR 11/3050/30; 1.0 PHR 11/3050/30; 1.0 Randomised controlled trial Interventional Randomised controlled trial Prevention 2016-09-30T00:00:00.000Z United Kingdom Scotland University of Dundee

Dundee United Kingdom DD2 4BF Patient Men aged 25 - 44 years living in socially disadvantaged communities who have consumed more than eight units of alcohol in a single drinking session at least twice in the preceding four weeks. Adult Male 798 1. Men who are currently attending an Alcohol Problem Service 2. Men who cannot communicate in English (verbally and by text message) 3. Men who will not be contactable by mobile phone for any part of the intervention period. 2014-03-01T00:00:00.000Z 2015-01-01T00:00:00.000Z Alcohol-related problems Mental and Behavioural Disorders Mental and behavioural disorders due to use of alcohol Current interventions as of 26/08/2014: Participants are randomised to two groups. Randomisation will be carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation will be stratified by participating centre and the recruitment method and restricted using block sizes of randomly varying lengths. 1. Intervention group: A series of interactive text messages will be delivered over a three month period. The intervention will be delivered in four stages: Stage 1 will welcome participants, establish empathy and raise awareness about alcohol harms. Stage 2 consists of a series of pre-intentional texts which will encourage intention to change. Stage 3 is designed to transform intentions into action. Stage 4 addresses relapse prevention to achieve sustained behaviour change. 2. The control group will also receive a series of interactive text messages for the twelve weeks of the intervention. The texts will be designed to be behaviourally neutral, by avoiding the behaviour change strategies employed in the active intervention. The messages will consist of jokes and interesting or unusual facts about health, unrelated to alcohol. They will be designed to maintain interest in the study to ensure that the control group complete the outcome assessments. Previous interventions: Participants are randomised to two groups. Randomisation will be carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation will be stratified by participating centre and the recruitment method and restricted using block sizes of randomly varying lengths. 1. Intervention group: A series of interactive text messages and images will be delivered over a three month period. The intervention will be delivered in four stages: Stage 1 will welcome participants, establish empathy and raise awareness about alcohol harms. Stage 2 consists of a series of pre-intentional texts which will encourage intention to change. Stage 3 is designed to transform intentions into action. Stage 4 addresses relapse prevention to achieve sustained behaviour change. 2. The control group will receive one text message per week for the twelve weeks of the intervention. The texts will be designed to be behaviourally neutral, by avoiding the behaviour change strategies employed in the active intervention. The messages will consist of jokes and interesting or unusual facts about health, unrelated to alcohol. They will be designed to maintain interest in the study to ensure that the control group complete the outcome assessments. Other Not Applicable The datasets generated during and/or analysed during the current study are not expected to be made available because the NHS Research Ethics approval for the study was on the basis of only the research team and individuals from regulatory authorities having access to the raw data. Not expected to be made available 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28702758 results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29927564 results 2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25526870 protocol Results Basic results see attached file ISRCTN07695192_BasicResults_22Sep17.pdf (added 23/11/2017)

results

results

protocol

Original line: 'See additional file ISRCTN07695192_BasicResults_22Sep17' Upload date: From file

f7c85ca3-37be-4993-868f-edadf23c4a9c d835db37-d564-48d0-b885-10122981609b 48b21e03-e520-4e8c-8751-92f485b3ea15 No Uploaded 23/11/2017 ISRCTN07695192_BasicResults_22Sep17.pdf 7859555b-bf70-4f0f-aaf7-b7a5fa40f4a5 true application/pdf 594719 644fc8240e3301d7edcaca9a18174b0c Iain K Crombie https://orcid.org/0000-0003-2623-3016 Scientific

University of Dundee Population Health Sciences Medical Reseach Institute The Mackenzie Building Kirsty Semple Way

Dundee United Kingdom DD2 4BF +44 (0)1382 383745 i.k.crombie@dundee.ac.uk Public University of Dundee and Tayside Health Board (UK) University/education https://ror.org/03h2bxq36 Non-commercial Public Health Research Programme http://dx.doi.org/10.13039/501100001921 10515845 true Reducing alcohol-related harm in disadvantaged men: development and feasibility assessment of a brief intervention delivered by mobile phone Can a brief intervention delivered by mobile reduce heavy drinking among disadvantaged young to middle aged men? Not provided at time of registration The change in frequency of heavy drinking (consumption of 8 or more units in a single session), measured at 3 months Measured at 3 months: 1. The extent to which the intervention has influenced perceptions of harms 2. The benefits of moderated drinking 3. Intentions for future drinking Old ethics approval format Tayside Committee on Medical Research Ethics A, 13/11/2009, ref: 09/S1401/78 10.1186/ISRCTN10515845 1.1 1.1 Feasibility study with a randomised controlled component Interventional Randomised controlled trial Prevention 2011-11-30T00:00:00.000Z United Kingdom Scotland Department of Public Health

Dundee United Kingdom DD2 4BF Patient 1. Men aged 25 - 44 years 2. Living in deprived urban communities 3. Have consumed 8 or more units of alcohol in a single drinking session at least twice in the preceding 4 weeks Adult Male 110 Cannot communicate (verbally and by text message) in English 2010-03-01T00:00:00.000Z 2011-11-30T00:00:00.000Z Alcohol-related problems Mental and Behavioural Disorders Mental and behavioural disorders due to use of alcohol A series of 28 interactive text messages and images to be delivered over a 4-week period to participants in both arms of the study. The intervention group will receive messages to address four areas: 1. Increasing awareness of and perceived risk of experiencing alcohol-related harm 2. Modifying the balance between perceived benefits and harms of alcohol 3. Addressing misperceptions about alcohol consumption by peers 4. Increasing the ability to refuse drinks The comparator group will receive the same number of text messages and images. These will cover the general health promotion messages from current government public health policy. These include diet, physical activity, smoking and mental wellbeing. The total duration of the intervention is 28 days. Participants will be followed up for 3 months. Behavioural Not provided at time of registration 2017 Results article in https://pubmed.ncbi.nlm.nih.gov/28295794/ results (added 08/10/2020) Results

results

e192b4b6-575d-4cdd-af5b-71854060dea5 90a905be-6c51-49fa-9e07-b151f764a4ec 5190fda1-50c4-476f-9092-1cdb3ed70c9a No Iain K Crombie Scientific

Department of Public Health Division of Clinical & Population Sciences & Education Mackenzie Building Kirsty Semple Way

Dundee United Kingdom DD2 4BF +44 (0)1382 420 102 abc@email.com Public University of Dundee (UK) University/education https://ror.org/03h2bxq36 Non-commercial National Institute for Health Research (NIHR) (UK) - Public Health Research Programme (ref: 09/3001/09)