Frontiers in Public Health (Nov 2015)
A pilot controlled trial to determine the feasibility, acceptability and effectiveness of a PAPA-based online intervention to address practical and perceptual barriers to medication adherence in Inflammatory Bowel Disease.
Abstract
Background Adherence to appropriately prescribed medication can reduce flare-ups and increase quality of life for people with inflammatory bowel disease (IBD). But, many people do not obtain the full benefits from maintenance treatment because of under use (known as nonadherence). The Perceptions and Practicalities Approach (PAPA) suggests that tailored support which meets the needs of the patient by identifying and addressing specific perceptual factors (e.g. beliefs about the illness and treatment) and practical factors (e.g. capabilities and resources) will increase motivation and ability to adhere to treatment. This study involved developing and piloting an online intervention which profiled people with IBD. Aim To conduct a pilot controlled trial to determine the feasibility, acceptability and effectiveness of a PAPA-based intervention to address perceptual and practical barriers to medication adherence in Inflammatory Bowel Disease, delivered online. Methods The intervention was developed using theory (PAPA), input from service users and experts in behavioural medicine, gastroenterology, pharmacy, clinical psychology and health psychology, and consideration of relevant behaviour change techniques. It was delivered through a website ('IBD-Helper'). Participants were aged 18 years or older, with IBD, and taking azathioprine and/or mesalazine. They were recruited via Crohn's and Colitis UK's website, social media and NHS clinics. Participants were consented, profiled on adherence barriers, then allocated to Intervention (access to the 'IBD-Helper' website which had content tailored to the barriers they reported) or Control (questionnaire follow-up only). Changes in perceptual and practical barriers to adherence were assessed using the Beliefs about Medicines Questionnaire (BMQ) and a new reported practical barriers scale. Secondary outcomes included adherence (Medication Adherence Report Scale and a Visual Analogue Scale), illness beliefs (Illness Perceptions Questionnaire), general beliefs about pharmaceutical medicines (BMQ), satisfaction with information about medicine (SIMS), healthcare seeking, quality of life (Short-form IBD Questionnaire), and anxiety and depression (HADS). Data was collected at baseline, and 1 and 3 months follow-up. Intervention participants also received a post-intervention feedback questionnaire. Results 1,267 potential participants completed the screening questionnaire, of which 329 participants were allocated to Intervention or Control. The groups were similar on baseline demographic, clinical and outcome measures. There was significant drop out over the course of the study with just under half (46.2%) of the sample completing all follow-up measures. Of the 153 participants allocated to the Intervention Group, 115 completed the 1-month follow-up, and 44 completed the 3-month follow-up. The Control Group consisted of 176 participants, with 154 completing the 1-month follow-up, and 108 completing the 3-month follow up. Primary Outcomes: There were indications that the intervention reduced perceptual barriers. The Intervention Group had significantly higher necessity beliefs and significantly lower medication concerns compared to Controls, at 1 (BMQ Necessity-Concerns Differential NCD M=0.76, SD=1.16 vs. M=0.25, SD=1.19, p<0.05) and 3 (NCD M=0.90, SD=1.24 vs. M=0.01, SD=1.17, p<0.001) month follow-ups. However, there was no significant difference in reported practical barriers to adherence between the Intervention and Control Groups at either of the follow-up time points. Secondary Outcomes: Intervention recipients reported higher satisfaction with information about the practical aspects of using IBD medication safely and to best effect compared to the Control Group at 1 month follow up (M=8.25, SD=2.10 vs. M= 7.27, SD=2.23, p<0.05), but this ceased to be significant at 3 months. An improvement in satisfaction with the information on potential problems associated with IBD medications was also evident in the Intervention Group compared to the Control Group, both at 1 month (M=6.03, SD=2.41 vs. M=5.08, SD=2.59, p<0.05), and at 3 months follow up (M=7.04, SD=2.26 vs. M=5.33, SD=2.67, p=0.001). The intervention was also associated with a statistically significant improvement in adherence compared to the Control Group. At 1 month, the Intervention Group reported significantly (p<0.01) fewer non-adherence episodes (n=9, 19.1%) compared to the Control Group (n=43, 37.6%). Intervention participants reported more positive views of pharmaceutical medication in general compared to the Control Group, with lower BMQ overuse (M=2.61, SD=0.87 vs. M=3.01, SD=0.92; p<0.05) and harm beliefs (M=2.02, SD=0.72 vs. M=2.29, SD=0.68; p<0.05) at 1 month and 3 months follow-up (Overuse M=2.62, SD=0.69 vs. M=3.07, SD=0.90, p<0.01; Harm M=1.99, SD=0.57 vs. M=2.26, SD=0.61, p=0.02). The Intervention Group also reported more positive perceptions of IBD compared to the Control Group, with higher treatment control beliefs at 3 months (M=7.69, SD=2.04 vs. M=6.61, SD=2.17, p<0.01), lower concern beliefs at 1 month (M=6.15, SD=2.55 vs. M=6.98, SD=2.13, p=0.01) and 3 months follow-up (M=6.13, SD=2.58 vs. M=6.97, SD=2.14, p=0.05), and lower emotional response to IBD at both 1 month (M=5.95, SD=2.68 vs. M=7.30, SD=2.23, p<0.01), and 3 months follow-up (M=5.92, SD=2.71 vs. M=7.24, SD=2.24, p<0.01). Usage/Participant Feedback: Intervention participants used IBD-Helper for between 0-73 minutes, with most participants spending 10 minutes or less on the intervention. Thirty-two participants in the Intervention Group completed an acceptability questionnaire and indicated that they had high satisfaction with the intervention and positive views of the intervention team. Conclusions The intervention was effective in addressing perceptual barriers to adherence, as well as having a positive impact on IBD-related illness perceptions: increasing treatment control beliefs, and reducing concerns and emotional response. Fewer episodes of non-adherence were reported in the Intervention Group compared to the Control Group. Satisfaction with information about IBD medication improved following the intervention. However, the number of reported practical barriers was similar between the Intervention and Control groups, suggesting that other support might need to be incorporated into the intervention. Limitations of this study include potential bias due to drop-out, potential lack of generalisability to patient populations not recruited online and a reliance on self-report rather than objective outcome measures. However, this controlled trial suggests that the IBD-Helper intervention may be an effective, feasible and acceptable method of addressing perceptual barriers to adherence.
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