Dataset Information

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study.

ABSTRACT:

Background

Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques.

Methods

Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.

Participants

PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers.

Interventions

Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n?=?32); or, (2) control, typically face-to-face meetings every 3?months with CF team (n?=?32).

Outcomes

RCT feasibility defined as: recruitment of ??48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ??85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV₁ percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n?=?14) and control (n?=?5) participants, interventionists (n?=?3) and CF team members (n?=?5).

Results

The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention?=?32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV₁ percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised.

Conclusions

With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible.

Trial registration

ISRCTN13076797 . Prospectively registered on 07/06/2016.

SUBMITTER: Hind D

PROVIDER: S-EPMC6458785 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study.

Hind Daniel D Drabble Sarah J SJ Arden Madelynne A MA Mandefield Laura L Waterhouse Simon S Maguire Chin C Cantrill Hannah H Robinson Louisa L Beever Daniel D Scott Alexander J AJ Keating Sam S Hutchings Marlene M Bradley Judy J Nightingale Julia J Allenby Mark I MI Dewar Jane J Whelan Pauline P Ainsworth John J Walters Stephen J SJ O'Cathain Alicia A Wildman Martin J MJ

BMC pulmonary medicine 20190411 1

<h4>Background</h4>Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques.<h4>Methods</h4>Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.<h4>Participants</h4>PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the ...[more]

PMID: 30975206

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Project description:ObjectivesAdherence to nebulizer treatment in adults with Cystic Fibrosis (CF) is poor, and interventions are needed. This research aimed to identify the factors affecting nebulizer adherence using the Theoretical Domains Framework (TDF) and to compare these for participants with different levels of adherence.DesignData-prompted interviews using the TDF.MethodsEighteen semi-structured interviews were conducted with adults with CF during which objectively measured adherence data were discussed. Framework analysis was used to code the data into TDF domains, and inductive qualitative content analysis was used to code different beliefs and experiences. Aspects of the TDF that differed between participants with different adherence levels were explored.ResultsFactors influencing adherence to treatment included all 14 domains of the TDF, 10 of which appeared to vary by adherence level: Skills; Memory and decision-making; and Behavioural regulation; Environmental context and resources; Social influences; Beliefs about consequences; Beliefs about capability; Reinforcement; Social role and identify; Intentions; Optimism; and Emotions.ConclusionsThis study is the first to use objectively measured adherence data in a data-prompted interview using the TDF framework to systematically assess the full range of factors potentially influencing adherence. The results highlighted that interventions need to consider issues of capability, opportunity, and motivation. Interventions that challenge dysfunctional beliefs about adherence and which support the development of routines or habits and problem-solving may be particularly useful for adults with CF. Statement of contribution What is already known? Adherence to medication in adults with cystic fibrosis is poor. Previous research has identified a range of contributing factors in relation to subjective reports of adherence. There is a wide discrepancy between self-reported adherence and objectively measured adherence. What this study adds A data-prompted interview using objectively measured adherence data enabled the systematic assessment of potential factors that could be targeted in an intervention to increase adherence. There were some differences in the factors that were identified by high and low adherers. There is not one-size fits all intervention for adherence to medication in cystic fibrosis.

Project description:BACKGROUND:Problems with prospective memory, which refers to the ability to remember future intentions, cause deficits in basic and instrumental activities of daily living, such as taking medications. Older adults show minimal deficits when they rely on mostly preserved and relatively automatic associative retrieval processes. On the basis of this, we propose to provide external cues to support the automatic retrieval of an intended action, that is, to take medicines. To reach this end, we developed the Medication Ambient Display (MAD), a system that unobtrusively presents relevant information (unless it requires the users' attention) and uses different abstract modalities to provide external cues that enable older adults to easily take their medications on time and be aware of their medication adherence. OBJECTIVE:This study aimed to assess the adoption and effect of external cues provided through ambient displays on medication adherence in older adults. METHODS:A total of 16 older adults, who took at least three medications and had mild cognitive impairment, participated in the study. We conducted a 12-week feasibility study in which we used a mixed methods approach to collect qualitative and quantitative evidence. The study included baseline, intervention, and postintervention phases. Half of the participants were randomly allocated to the treatment group (n=8), and the other half was assigned to the control group (n=8). During the study phases, research assistants measured medication adherence weekly through the pill counting technique. RESULTS:The treatment group improved their adherence behavior from 80.9% at baseline to 95.97% using the MAD in the intervention phase. This decreased to 76.71% in the postintervention phase when the MAD was no longer being used. Using a one-way repeated measures analysis of variance and a post hoc analysis using the Tukey honestly significant difference test, we identified a significant statistical difference between the preintervention and intervention phases (P=.02) and between the intervention and postintervention phases (P=.002). In addition, the medication adherence rate of the treatment group (95.97%) was greater than that of the control group (88.18%) during the intervention phase. Our qualitative results showed that the most useful cues were the auditory reminders, followed by the stylized representations of medication adherence. We also found that the MAD's external cues not only improved older adults' medication adherence but also mediated family caregivers' involvement. CONCLUSIONS:The findings of this study demonstrate that using ambient modalities for implementing external cues is useful for drawing the attention of older adults to remind them to take medications and to provide immediate awareness on adherence behavior. TRIAL REGISTRATION:ClinicalTrials.gov NCT04289246; https://tinyurl.com/ufjcz97.

Project description:Preventative inhaled treatments in cystic fibrosis will only be effective in maintaining lung health if used appropriately. An accurate adherence index should therefore reflect treatment effectiveness, but the standard method of reporting adherence, that is, as a percentage of the agreed regimen between clinicians and people with cystic fibrosis, does not account for the appropriateness of the treatment regimen. We describe two different indices of inhaled therapy adherence for adults with cystic fibrosis which take into account effectiveness, that is, "simple" and "sophisticated" normative adherence.Denominator adjustment involves fixing a minimum appropriate value based on the recommended therapy given a person's characteristics. For simple normative adherence, the denominator is determined by the person's Pseudomonas status. For sophisticated normative adherence, the denominator is determined by the person's Pseudomonas status and history of pulmonary exacerbations over the previous year. Numerator adjustment involves capping the daily maximum inhaled therapy use at 100% so that medication overuse does not artificially inflate the adherence level.Case A is an example of inhaled therapy under prescription based on Pseudomonas status resulting in lower simple normative adherence compared to unadjusted adherence. Case B is an example of inhaled therapy under-prescription based on previous exacerbation history resulting in lower sophisticated normative adherence compared to unadjusted adherence and simple normative adherence. Case C is an example of nebulizer overuse exaggerating the magnitude of unadjusted adherence.Different methods of reporting adherence can result in different magnitudes of adherence. We have proposed two methods of standardizing the calculation of adherence which should better reflect treatment effectiveness. The value of these indices can be tested empirically in clinical trials in which there is careful definition of treatment regimens related to key patient characteristics, alongside accurate measurement of health outcomes.

Project description:BACKGROUND:Over the last two decades, lifespan has increased significantly for people living with cystic fibrosis (CF). However, several studies have demonstrated that many young adults with CF report mental health problems and poor adherence to their prescribed treatments, challenging their long-term physical health. Treatment guidelines recommend interventions to improve adherence and self-management. The aim of this study was to test the feasibility of a life coaching intervention for young adults with CF. METHODS:A randomized, controlled feasibility study was conducted at the CF Center at Copenhagen University Hospital, Rigshospitalet. Participants were young adults with CF, aged 18-30 years without severe intellectual impairments. Participants were randomized to either life coaching or standard care. The intervention consisted of up to 10 individual, face-to-face or telephone coaching sessions over a period of 1 year. Primary outcomes were recruitment success, acceptability, adherence to the intervention, and retention rates. Secondary outcome measures included health-related quality of life, adherence to treatment, self-efficacy, pulmonary function, body mass index, and blood glucose values. RESULTS:Among the 85 eligible patients approached, 40 (47%) were enrolled and randomized to the intervention or control group; two patients subsequently withdrew consent. Retention rates after 5 and 10 coaching sessions were 67% and 50%, respectively. Reasons for stopping the intervention included lack of time, poor health, perceiving coaching as not helpful, lack of motivation, and no need for further coaching. Coaching was primarily face-to-face (68%). No significant differences were found between the groups on any of the secondary outcomes. CONCLUSION:Both telephone and face-to-face coaching were convenient for participants, with 50% receiving the maximum offered coaching sessions. However, the dropout rate early in the intervention was a concern. In future studies, eligible participants should be screened for their interest and perceived need for support and life coaching before enrollment.

Project description:BackgroundThere are controversies about the most effective treatment to eradicate first growth of Pseudomonas aeruginosa (P aeruginosa) from the lower airways of patients with cystic fibrosis (CF). UK guidelines recommend oral treatment, but some advocate intravenous (IV) treatment. The objective of this study was to assess the feasibility of conducting a randomised controlled trial comparing two treatment strategies to eradicate P aeruginosa in CF patients.Methods/principal findingsTwo surveys were conducted. Survey [1] included clinicians who were responsible for the treatment of individuals with CF, to assess their clinical practice, opinions and numbers of potentially eligible patients. Survey [2] included adults and young people aged 13 years or more with CF and parents of children with CF aged less than 13 years, identified at six UK CF centres, who fulfilled eligibility criteria for the proposed clinical trial, to assess their views about the interventions and their willingness to participate in the trial. Generally clinicians treat first or new growth of P aeruginosa with oral antibiotics, but 90% reported that they would consider IV treatment of first isolation of P aeruginosa. 74% of clinicians would consider recruiting their patients and 45% of consumers would consider entry for themselves or their children into a trial comparing oral with intravenous antibiotics. The median rate per annum for first or new growths of P aeruginosa in adults was 3% (range 1% to 9%) and in children was 10% (range 3% to 23%). If the trial was conducted across the UK, with a consent rate of 45%, then the number of eligible patients per annum who would be willing to take part in a study would be approximately 41 adults and 203 children.ConclusionsThis work demonstrates the importance of feasibility studies in preparation for multicentre clinical trials. It confirmed the uncertainty amongst clinicians and patients about the clinical question, enabled assessment of the number of potentially eligible patients, the proportion of patients and clinicians prepared to participate and aspects of trial design which might encourage this. It showed that a clinical trial was feasible, but only if patients were recruited from across United Kingdom.

Dataset Information

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study.

Background

Methods

Participants

Interventions

Outcomes

Results

Conclusions

Trial registration

Publications

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study.

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