Condition category
Circulatory System
Date applied
12/07/2016
Date assigned
19/07/2016
Last edited
19/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with long term health problems such as heart failure sometimes don't take all their suggested medications (poor compliance). One reason is that people forget to take their medicine at the prescribed time. This can result in worsening health, more hospital admissions and a reduced quality of life for the person, as well as higher health service costs. By helping patients to take their heart failure medicines regularly every day, patients are more likely to keep well and free of heart failure symptoms. In turn this can help prevent admission to hospital and improve quality of life. One study has shown that if medicine taking is better, there is an improvement in life expectancy. This small study aims to find out how well an electronic reminder system (My Health Tag) is, to help improve compliance in patients with heart failure. My Health Tag is a small electronic device that will remind patients when to take their heart failure tablets. There are two parts to the device. One is attached to the tablet packet and will alert the participant about which tablet is due to be taken. The other part is a reminder display which can be placed in the home separately from the tablets and will remind them that they are due to take some tablets.

Who can participate?
Adult with heart failure who live in the Bristol area who are currently taking medication for heart failure.

What does the study involve?
Participants are randomly allocated to one of two groups. Both groups receive the My Health Tag device and standard care in a random order. At the start of the study, participants have their medical and medication history take, as well as having their current levels of breathlessness and heart health measured. Participants who have been allocated to receive the device for the first four weeks (group AB) are shown how to use the device, which is programmed by the study team to remind them when to take their heart failure tablets. Participants assigned to standard care for the first four weeks (Group BA) are shown how the device works but it is not installed at this point. After four weeks, the two groups switch treatments so the group with the device receives standard care and the standard care group receives the device. At the end of each four week period, both groups have their heart failure tablets counted, are asked about any new health problems and have their breathlessness levels assessed. A blood and urine sample is also collected from the participant and they are asked to post another urine sample to the research team two weeks later.

What are the possible benefits and risks of participating?
There are no direct benefits to participants other than the knowledge that they may be helping to improve care for all future patients. Participants may appreciate the additional contact from the research team. It is possible that the reminder system will help participants to get into good habits of remembering to take their medication on time. There is a small risk of bruising or pain when the blood samples are taken and it is possible the technology may fail or the participant becomes completely reliant on the device to remind them to take their tablets.

Where is the study run from?
Bristol Heart Institute (UK)

When is the study starting and how long is it expected to run for?
March 2015 to December 2016

Who is funding the study?
Small Business Research Initiative Healthcare (UK)

Who is the main contact?
Ms Ruth Bowles
Ruth.Bowles@UHBristol.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Ruth Bowles

ORCID ID

Contact details

C701 BHI Offices
Bristol Heart Institute
University Hospitals Bristol NHS Foundation Trust
Bristol
BS2 8HW
United Kingdom
+44 117 342 6624
Ruth.Bowles@UHBristol.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20872

Study information

Scientific title

A single centre, randomized, crossover early stage clinical study to evaluate the effects of my health tag on improving medicines adherence in patients with heart failure

Acronym

Study hypothesis

The aim of this feasibility study is to evaluate the usefulness of an electronic reminder system (My Health Tag) in improving medication compliance in patients with chronic heart failure.

Ethics approval

South West - Exeter Research Ethics Committee, 06/04/2016, ref: 16/SW/0032

Study design

Single-centre randomised crossover study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cardiovascular disease, Primary sub-specialty: Heart failure; UKCRC code/ Disease: Cardiovascular/ Hypertensive diseases

Intervention

Following informed consent all participants will have a medical and medication history taken. They will undergo ECG, blood pressure, breathlessness and heart rate measurements.

All patients will participate in both arms of the study. The order will be determined using a random number table, generated independently by the study statistician. The assignment will be provided via sealed envelopes that are sequentially numbered and opened in number order.

Study arm AB (receive My Health Tag for first 4 weeks, followed by standard care for 4 weeks):
Participants assigned to receive the device for the first 4 weeks will be shown how to use the device and the device will be programmed to remind them when to take their heart failure medications. Their heart failure medications will be counted and they will complete a quality of life and a medication adherence questionnaire, they will also be asked if any new health problems have occurred. A blood and urine sample will be collected from the participant and they will be asked to post another urine sample to the research team 2 weeks later. At the end of the 4 weeks the My Health Tag device will be removed. Participants will be reminded to take their medications as per standard care. Their heart failure medications will be counted and they will complete a quality of life and a medication adherence questionnaire, they will also be asked if any new health problems have occurred and their level of breathlessness will be assessed. A blood and urine sample will be collected from the participant and they will be asked to post another urine sample to the research team 2 weeks later. At the end of the second 4 weeks (week 8) their heart failure medications will be counted and they will complete a quality of life and a medication adherence questionnaire, they will also be asked if any new health problems have occurred and their level of breathlessness will be assessed. A blood and urine sample will be collected from the participant. This will be the end of all study participation for the participant.

Study arm BA (receive standard care for first 4 weeks, followed by My Health Tag device for 4 weeks):
Participants assigned to standard care for the first 4 weeks will be shown how the device works but it will not be installed at this point.
Their heart failure medications will be counted and they will complete a quality of life and a medication adherence questionnaire, they will also be asked if any new health problems have occurred. A blood and urine sample will be collected from the participant and they will be asked to post another urine sample to the research team 2 weeks later. At the end of the 4 weeks participants will be shown how to use the My Health Tag device and the device will be programmed to remind them when to take their heart failure medications. Their heart failure medications will be counted and they will complete a quality of life and a medication adherence questionnaire, they will also be asked if any new health problems have occurred and their level of breathlessness will be assessed. A blood and urine sample will be collected from the participant and they will be asked to post another urine sample to the research team 2 weeks later. At the end of the second 4 weeks (week 8) the My Health Tag device will be removed. Their heart failure medications will be counted and they will complete a quality of life and a medication adherence questionnaire, they will also be asked if any new health problems have occurred and their level of breathlessness will be assessed. A blood and urine sample will be collected from the participant. This will be the end of all study participation for the participant.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Percentage of ACE/ARB and Beta Blocker heart failure tablets taken during the study period, calculated from the pill count taken by the research nurse at baseline, 4, and 8 weeks

Secondary outcome measures

1. Mean difference between groups, in the proportion of patients with chronic heart failure taking >80% of prescribed pills (ACEi/ARB and BB) over a four-week period
2. Mean difference between groups in change in MMAS-8 scores measured at baseline, 4, and 8 weeks between baseline and the end of the treatment block
3. Mean difference between groups in change in urine metabolite numbers, measured at baseline, 2, 4, 6 and 8 weeks between baseline and the end of the treatment block

Overall trial start date

17/03/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age over 18 years
2. Able to provide informed consent
3. Diagnosis of heart failure made more than one month prior to enrollment
4. On medication for heart failure including ACEi/ARB and B-blocker
5. Has 4 week supply of ACE/ARB and B blocker
6. Live in postcode areas BS1 – BS16
7. Able to read and understand instructions in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant exclusion criteria

1. Medication given by partner or other care-provider
2. Use of dosette box
3. History of advanced dementia
4. Planned travel away for home for more than 7 consecutive days during the study period
5. 3G and WiFi signal absent or very poor in patient’s home
6. Expected to change dose of ACEi/ARB or BB during the study period

Recruitment start date

15/04/2016

Recruitment end date

31/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Heart Institute
Upper Maudlin Street
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust

Sponsor details

Research and Innovation
Level 3
UH Bristol Education and Research Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
+44 117 342 0233
Jake.Harley@uhbristol.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Small Business Research Initiative Healthcare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication and dissemination of study results is planned. Local publication on Trust website, journals, and conferences. A summary of the study will be made available to the participants and other interested parties.

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes