Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study.
BMC Pulm Med
; 19(1): 77, 2019 Apr 11.
Article
en En
| MEDLINE
| ID: mdl-30975206
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 11 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.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Educación del Paciente como Asunto
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Fibrosis Quística
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Cumplimiento de la Medicación
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Automanejo
Tipo de estudio:
Clinical_trials
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Prognostic_studies
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Qualitative_research
Límite:
Adult
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Female
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Humans
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Male
Idioma:
En
Año:
2019
Tipo del documento:
Article