ArticlePilot and feasibility studies2023
Adherence therapy for adults with type 2 diabetes: a feasibility study of a randomized controlled trial.
Article in Pilot and feasibility studies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAdherence Therapy is a candidate intervention to promote consistent medication taking in people with type 2 diabetes. The aim of this study was to establish the feasibility of conducting a randomized controlled trial of adherence therapy in people with type 2 diabetes who were non-adherent with medication.
methodsThe design is an open-label, single-center, randomized controlled feasibility trial. Participants were randomly allocated to receive either eight sessions of telephone-delivered adherence therapy or treatment as usual. Recruitment occurred during the COVID-19 pandemic. Outcome measures-adherence, beliefs about medication, and average blood glucose (sugar) levels (HbA1c)-were administered at baseline and after 8 weeks (TAU group) or at the completion of the treatment (AT group). Feasibility outcomes included the number of people approached to participate in the trial and the numbers that consented, completed study measures, finished treatment with adherence therapy, and dropped out of the trial. Fieldwork for this trial was conducted in the National Guard Hospital, a tertiary care provider, in the Kingdom of Saudi Arabia.
resultsSeventy-eight people were screened, of which 47 met eligibility criteria and were invited to take part in the trial. Thirty-four people were excluded for various reasons. The remaining thirteen who consented to participate were enrolled in the trial and were randomized (AT, n = 7) (TAU, n = 6). Five (71%) of the seven participants in the adherence therapy arm completed treatment. Baseline measures were completed by all participants. Week 8 (post-treatment) measures were completed by eight (62%) participants. Dropout may have been linked to a poor understanding of what was involved in taking part in the trial.
conclusionsIt may be feasible to conduct a full RCT of adherence therapy, but careful consideration should be given to developing effective recruitment strategies, consent procedures, rigorous field testing, and clear support materials.
trial registrationThe trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12619000827134, on the 7th of June 2019.
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