Improving Adherence to Medication in Stroke Survivors

ISRCTN ISRCTN38274953
DOI https://doi.org/10.1186/ISRCTN38274953
Secondary identifying numbers CZH/4/569
Submission date
03/12/2009
Registration date
18/01/2010
Last edited
27/06/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Ronan O'Carroll
Scientific

University of Stirling
Stirling
FK9 4LA
United Kingdom

Email reo1@stir.ac.uk

Study information

Study designSingle centre randomised controlled pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleImproving Adherence to Medication in Stroke Survivors: a single centre randomised controlled pilot study
Study acronymIAMSS
Study objectivesThis project will pilot the feasibility of a brief intervention in stroke and transient ischaemic attack (TIA) patients exhibiting sub-optimal adherence to medication with the aim of:
1. Establishing a better medication taking routine using an implementation intentions intervention, and
2. Eliciting and modifying any emergent erroneous beliefs regarding the patient's medication and their stroke

We will test whether medication routines and beliefs are changeable, and if the results are promising, this will pave the way for a larger randomised controlled trial (RCT) to determine whether adherence is improved, physiological risk is changed (e.g. via reduction in blood pressure) and rate of recurrent vascular events is reduced.

The research questions addressed by this study are:
1. Is the brief intervention feasible, understandable and acceptable (e.g. uptake/attrition)?
2. Does the intervention improve adherence?
3. Is improvement in adherence mediated by:
3.1. Changes in illness and medication beliefs, and/or
3.2. Reduced forgetting?
4. What effect size is observed to inform the power calculation for a larger, more definitive study?
Ethics approval(s)Lothian NHS Board, South East Scotland Research Ethics Committee 02, 30/10/2009, ref: 09/S1102/36
Health condition(s) or problem(s) studiedStroke/transient ischaemic attack
InterventionIntervention group:
Two brief sessions, two weeks apart with a trained RA, lasting approximately 30 - 45 minutes each. Session 1 will focus on helping each patient draw up a specific plan, so as to establish a better medication-taking routine using an implementation intentions approach. Patients will be helped to complete an individualised worksheet plan for each scheduled daily dose of antihypertensive medication. The participant and RA will both keep a copy of the plan. After completing the implementation intention worksheet in session 1, participants will then complete the Brief Illness Perceptions Questionnaire (BIPQ), and the Beliefs about Medications Questionnaire (BMQ). The participants' responses on these measures will be used as the basis for eliciting and challenging dysfunctional illness and medication beliefs in Session 2. Baseline blood pressure readings will be taken during Session 1. At Session 2, the effectiveness of the implementation intentions plan and any barriers/difficulties in following the plan will be reviewed, with appropriate coping strategies/plans developed collaboratively. This session will also focus on eliciting and, if appropriate, challenging patients' beliefs regarding their medication, e.g. beliefs regarding toxicity, dependence, fears regarding medications interacting harmfully, etc. The aim here will be to correct any misperceptions and provide evidence so that participants' medication necessity beliefs come to outweigh their medication concerns beliefs. Modification of erroneous beliefs about stroke will be based on the model of Petrie, who elicited and modified patients' dysfunctional beliefs regarding their recent myocardial infarction. This resulted in faster return to work and lower angina symptoms at 3 months. If the RA is unable to answer any specific questions regarding the patient's stroke or medication, then immediately following the interview, the RA will email the query to one of the stroke consultant experts on the research team, and the RA will then telephone the patient with the information within 7 days of the interview. At the end of session 2, the RA will fill each participant's MEMS medication bottle with the following month's supply of antihypertensive medication. We propose using the patients existing supply of antihypertensive medication. A check will be taken at session 1, and if supplies are running low, participants will be asked to obtain their repeat prescription in advance of session 2. For each of the next three months, the RA will repeat this process, and also take an electronic reading from the MEMS cap, downloading the data on to a laptop PC for later analysis. At the final visit, the outcome measures will be administered.

Treatment as Usual (TAU) control condition:
Participants in the control group will receive the same number of RA visits, and will also complete the MARS, BMQ, BIPQ, MEMS recordings, and BP recordings at baseline and at three month follow up. During the first 2 sessions, the RA will also engage the TAU participants in non-medication related conversation, e.g. how they are feeling, how they are spending their time, etc., in an attempt to provide some control for non-specific effects of attention/social contact. All interviews will be timed and digitally audio-recorded and transcribed for supervision feedback and check on treatment fidelity.
Intervention typeOther
Primary outcome measureMedication adherence recorded using MEMS (Medication Event Monitoring System, MEMS® Aardex Ltd, Switzerland) pill containers which electronically record openings. We shall use the following main outcomes, counting each opening as a presumptive dose:
1. Percentage of doses taken
2. Percentage of days on which the correct number of doses was taken
3. Percentage of doses taken on schedule
Secondary outcome measures1. MARS self-reported adherence of all secondary preventative medication
2. Systolic and diastolic blood pressure

Recorded at baseline and 3-month follow-up.
Overall study start date01/12/2009
Completion date30/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsWe aim to recruit 60 people into the trial (30 in each arm)
Key inclusion criteria1. Male and female patients who have suffered first-time stroke (ischaemic and haemorrhagic) or transient ischaemic attack (TIA)
2. Age range 18 + years (no upper age range)
3. Discharged from the Edinburgh Western General Hospital stroke units and clinics
4. Prescribed secondary antihypertensive medication on discharge
5. Exhibiting sub-optimal adherence on the Medication Adherence Report Scale (score of 24 or less)
6. Living at home
7. Responsible for own medication
Key exclusion criteria1. Age below 18 years
2. Marked cognitive impairment (Mini-Mental State Examination [MMSE] less than 23)
3. Significant dysphasia (Frenchay screen greater than 13/20)
4. Already using Dosette boxes (or similar) to improve their medication adherence
5. Participants who are not responsible for their own medication
Date of first enrolment01/12/2009
Date of final enrolment30/06/2012

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

University of Stirling
Stirling
FK9 4LA
United Kingdom

Sponsor information

University of Stirling (UK)
University/education

-
Stirling
FK9 4LA
Scotland
United Kingdom

Email jill.dykes@stir.ac.uk
Website http://www.external.stir.ac.uk/
ROR logo "ROR" https://ror.org/045wgfr59

Funders

Funder type

Government

Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZH/4/569)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 24/02/2010 Yes No
Results article results 01/12/2013 Yes No