Adherence therapy for adults with type 2 diabetes: a feasibility study of a randomized controlled trial.
Adherence
Adherence therapy
Compliance
Concordance
Diabetes
Feasibility trial
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
27 Apr 2023
27 Apr 2023
Historique:
received:
26
05
2022
accepted:
10
04
2023
medline:
28
4
2023
pubmed:
28
4
2023
entrez:
27
4
2023
Statut:
epublish
Résumé
Adherence 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. The 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. Seventy-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. It 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. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12619000827134, on the 7th of June 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Adherence 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.
METHODS
METHODS
The 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.
RESULTS
RESULTS
Seventy-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.
CONCLUSIONS
CONCLUSIONS
It 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 REGISTRATION
BACKGROUND
The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12619000827134, on the 7th of June 2019.
Identifiants
pubmed: 37106431
doi: 10.1186/s40814-023-01294-2
pii: 10.1186/s40814-023-01294-2
pmc: PMC10134646
doi:
Types de publication
Journal Article
Langues
eng
Pagination
71Informations de copyright
© 2023. The Author(s).
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