Condition category
Not Applicable
Date applied
24/04/2014
Date assigned
24/07/2014
Last edited
24/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
As people live longer, the numbers living with long-term conditions is increasing in the UK and worldwide. In fact, a substantial proportion of the UK population now live with more than one long-term condition, the likelihood that someone will do so increasing with age. Many people with long-term conditions are now managed in primary care with referral to specialist care only when strictly necessary and for short periods e.g. for specific diagnostic assessments, for surgical interventions or specialist treatments. Medication plays an important role in the way many patients with long-term conditions manage their conditions day to day. However, many people with long-term conditions have problems taking their medication as prescribed. These difficulties can have significant negative impacts on the longer term health of the individual. Poorer adherence has been shown to be associated with increased mortality and poorer quality of life, and can also be costly for the NHS through greater service use and increased hospital admissions among those whose adherence is poor. People with more than one long-term condition are particularly likely to have difficulties in taking medication as prescribed as their medication regimes are more likely to be complex and patients may prioritize one condition over another.
Although there are some methods that have been shown to be effective in improving adherence to medication in patients with long-term conditions, the down-side is that these are often complex and require significant professional time and support. This reduces their usefulness in a resource-constrained healthcare system. There is therefore a need to complement these existing methods with ones that are simpler, more efficient and have sufficient 'reach' into the population to support the large number of patients with long-term conditions. Research has suggested that a psychological method known as 'self-affirmation' may be effective at improving adherence to medications among those with long-term health problems. Self-affirmation is a way of bolstering the individual against the threat posed by negative personally-relevant health messages (e.g. a message about the importance of taking medication as prescribed if you have a long-term condition) so that individuals are more receptive to that information. In practice self-affirmation involves activities such as writing an essay about one’s positive personal characteristics or constructing a plan to remember one's positive attributes or personal values when feeling anxious or stressed. Self-affirmation has been shown to be effective at getting people who are chronically ill (people with end-stage renal failure) to adhere better to their medication. However, it has not yet been tested with people with the kind of long-term conditions typically managed in primary care (e.g. coronary heart disease, chronic obstructive pulmonary disease, depression, type 2 diabetes, arthritis).
Before undertaking a larger-scale study to look at the effectiveness of self-affirmation for improving adherence to prescribed medication in primary care patients with multiple long-term conditions, it is necessary to ensure that self-affirmation is acceptable to this patient group and that the study methods employed will be suitable. We are therefore undertaking a small-scale pilot study to explore these issues.

Who can participate?
Participants will be recruited through their GP (primary care) practice in Greater Manchester, UK. To be eligible to take part in the study, a person will need to be aged 50+ and have two or more of five long-term conditions commonly managed in primary care (depression, chronic obstructive pulmonary disease, type 2 diabetes, arthritis and coronary heart disease).

What does the study involve?
Participants will be randomly allocated to either a self-affirmation (intervention) group or a no self-affirmation control group. Participants will be sent an invitation letter and study pack containing the first study questionnaire from their practice. As well as study measures, the first questionnaire will contain the self-affirmation task (for the intervention group only) and a health message about the importance of taking medication as prescribed (for both groups). One month later participants will be sent a second questionnaire to complete.

What are the possible benefits and risks of participating?
The information participants provide in this study will be useful in exploring the possibilities of a method that could help support people living with long-term conditions to take their medication as prescribed. Participants will also receive accurate health information about the possible detrimental effects of not taking their medication as prescribed. The study also provides an opportunity for participants to reflect on this issue. Risks to participants in the study are relatively slight. There is a slight risk of mild distress in response to the questionnaires which contain the health message, questions on adherence or physical health, and questions on mood. We have been upfront about this content in the participant information sheet and provided information about where to seek further help to manage this risk. A second risk relates to the fact that it is not possible to go into detail upfront about the nature of self-affirmation with participants as evidence indicates that this might undermine the effectiveness of the method. To avoid any unnecessary distress this may cause we are providing a full debrief to participants as soon as possible with a full explanation of self-affirmation and why it was not possible to go into more detail prior to this point and also reminding participants that they reserve the right to pull out even at that late stage in the study. Previous studies of self-affirmation with similar methodologies have gone ahead successfully with no reported problems so we do not anticipate that this will be a major issue.

Where is the study run from?
University of Manchester (UK).

When is the study starting and how long is it expected to run for?
The study started in May 2014 and will run until August 2014.

Who is funding the study?
The study is being funded by the NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre (GM PSTRC).

Who is the main contact?
Dr Charlotte Garrett
Tel: +44 (0) 161 3067040
charlotte.garrett@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chris Armitage

ORCID ID

Contact details

Manchester Centre for Health Psychology
School of Psychological Sciences
University of Manchester
Coupland Street
Oxford Road
Manchester
M13 9PL
United Kingdom
chris.armitage@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Minimal Interventions to Improve Medication Adherence in Multimorbidity (MINIMA) study

Acronym

MINIMA

Study hypothesis

In this study we are investigating the acceptability of a self-affirmation intervention for improving medication adherence in people with multiple long-term conditions and the feasibility of methods that could be used in a randomised controlled trial of effectiveness of the intervention in this patient group.

Ethics approval

North West –Liverpool Central NRES Committee, 07/05/2014, Project REC reference: 14/NW/0282 – approval pending

Study design

Randomized controlled feasibility and acceptability pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Common long-term conditions (depression, coronary heart disease, chronic obstructive pulmonary disease, type 2 diabetes and arthritis [osteo and rheumatoid]), specifically multimorbidity of these

Intervention

Condition 1: Intervention group: Self-affirmation task plus health message
Condition 2: Control group: Health-message only control group

1 month follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Acceptability of the intervention and feasibility of study methods will be assessed by looking at:
1. Recruitment
2. Retention
3. Characteristics of responders versus non-responders
4. Engagement with the intervention (intervention group only)
5. The proportion of positive to negative comments made in response to questions asked about the experience of the intervention (intervention group only), and of taking part in the study (both groups)
6. Proportion of questionnaire correctly completed

Secondary outcome measures

N/A

Overall trial start date

12/05/2014

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary care patients aged 50+
2. Two or more of five common long-term conditions (depression, chronic obstructive pulmonary disease [COPD], type 2 diabetes, arthritis [osteo and rheumatoid] and coronary heart disease)
3. Participants must be fluent in written English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

Patients suffering from a condition which impairs their ability to provide informed consent or otherwise means that they are considered unsuitable to approach by their primary care team

Recruitment start date

12/05/2014

Recruitment end date

31/08/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Centre for Health Psychology
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Lynne Macrae
Faculty Research Practice Coordinator
Research Office - Faculty of Medicine
The University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
lynne.macrae@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre (GM PSTRC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes