Adherence therapy for adults with type 2 diabetes: a feasibility study of a randomized controlled trial

Fatimah Alenazi; Monica Peddle; Daniel Bressington; Moeber Mahzari; Richard Gray

doi:10.1186/s40814-023-01294-2

Adherence therapy for adults with type 2 diabetes: a feasibility study of a randomized controlled trial

Pilot Feasibility Stud. 2023 Apr 27;9(1):71. doi: 10.1186/s40814-023-01294-2.

Authors

Fatimah Alenazi^{1

2}, Monica Peddle³, Daniel Bressington^{4

5}, Moeber Mahzari^{6

7

8}, Richard Gray⁹

Affiliations

¹ School of Nursing and Midwifery, La Trobe University, Melbourne, Victoria, 3086, Australia. F.alenazi@latrobe.edu.au.
² Department of Public Health, College of Public Health and Health Informatics, Qassim University, AlBukayriyah, Kingdom of Saudi Arabia. F.alenazi@latrobe.edu.au.
³ School of Nursing and Midwifery, Deakin University, Melbourne, Australia.
⁴ Faculty of Nursing, Chiang Mai University, 110/406 Inthawaroros Road, Sri Phum District, Chiang Mai, 50200, Thailand.
⁵ Faculty of Health, Charles Darwin University, Ellengowan Drive, Darwin, Northern Territory, 0810, Australia.
⁶ College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.
⁷ Department of Medicine, Division of Endocrinology, Ministry of National Guard, Health Affairs, Riyadh, Kingdom of Saudi Arabia.
⁸ King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
⁹ School of Nursing and Midwifery, La Trobe University, Melbourne, Victoria, 3086, Australia.

Abstract

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: 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: 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: 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: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12619000827134, on the 7th of June 2019.

Keywords: Adherence; Adherence therapy; Compliance; Concordance; Diabetes; Feasibility trial.