Table 2.
Framework of treatment fidelity strategies.
| Components | Goal | Strategies |
|---|---|---|
| Study design | Maintain consistent treatment doses within and across conditions. | The GBI intervention protocol is structured to comprise four sessions. Facilitators will adhere to the provided intervention manual for consistent delivery. Researchers will observe a mock intervention by facilitators to ensure delivery appropriateness, provide feedback post-observation, and address any issues. Strict adherence to the allocated time for each activity is mandatory for all facilitators. |
| Plan for implementation setbacks. | All staff members in the studied facilities have received training to facilitate the GBI intervention. This training equips them with the skills needed to conduct the intervention independently, even without the initial facilitators. This contingency plan ensures the intervention's uninterrupted progress, even in unforeseen circumstances. | |
| Provider training | Standardise training. | The study will employ a team of skilled facilitators for the GBI intervention. These facilitators will receive joint training to maintain consistent delivery of the intervention. Researchers will observe mock interventions during training sessions conducted by the involved facilitators to evaluate their performance. This observation aims to provide feedback, identify areas for improvement, and ensure that the intervention adheres to the intended delivery standards. |
| Ensure provider skill acquisition. | Standardised patients or pilot participants (role-playing) will be used to ensure effective and consistent intervention implementation. The observation of the implementation process will assess the competency and qualifications of the facilitators involved, allowing for necessary adjustments as needed. | |
| Minimise “drift” in provider skills. | Researchers will maintain ongoing monitoring of the intervention conducted during the study to ensure adherence to the protocol and consistency. Following each PICC session, facilitators can discuss any issues they encountered with the intervention during a post-mortem meeting with researchers. Participants must complete a workbook to document the delivery of specific treatment components, which will be a valuable resource for evaluating the intervention. | |
| Accommodate provider differences. | The study's facilitators will be pharmacists employed at the primary health clinic of the selected study site. All facilitators will possess uniform knowledge and undergo training to ensure consistent program implementation. This homogeneity within the facilitator pool will promote consistent and effective intervention delivery to all participants. | |
| Treatment delivery | Control for provider differences. | To assess the facilitators' effectiveness, participants were asked to rate their satisfaction level after each session through a questionnaire. These ratings were examined following each session. A qualitative interview was conducted after the study to delve deeper into participants' perceptions and collect additional insights. |
| Reduce differences within the treatment. | A scripted intervention protocol is made available to facilitators during training, which is then evaluated through a mock intervention to ensure standardisation of delivery. | |
| Ensure adherence to the treatment protocol. | The module's script is carefully constructed to provide clear and concise instructions for the facilitator. In tandem with this script, a workbook is provided for the facilitator and participants to complete together, serving as both an engaging activity and a means of verifying the content delivered. | |
| Minimise contamination between conditions | The study randomly assigned participants to the PICC or control group. To guarantee each participant received individualised treatment, they were placed in their respective groups and provided with a comprehensive orientation to the study procedures. The interventions were distinctly defined, with the PICC group participating in group sessions and the DMTAC group having one-on-one sessions. | |
| Treatment receipt | Ensure participant comprehension. | Program participants will receive a workbook featuring session-related questions to facilitate their learning. Any arising misconceptions will be promptly addressed to ensure a clear understanding of the material. After the intervention, researchers will conduct a qualitative interview to evaluate the program's effectiveness and impact. |
| Ensure the participant's ability to use cognitive skills. | At the end of each session, the facilitator will review the participant workbooks to verify comprehension of the target content, correcting any misconceptions. Additionally, quizzes will be administered to participants to evaluate their understanding of the material covered during the session. | |
| Ensure the participant's ability to perform behavioural skills. | Participant's compliance with the program will be evaluated by administering the MYMATT questionnaire in conjunction with HbA1C testing. Pre- and post-intervention testing will measure behaviour change due to the program. | |
| Enactment of treatment skills | Ensure participant use of cognitive skills. | Using quizzes, workbooks, and the Malay version of the Modified Diabetes Knowledge Test (DKT) questionnaire will effectively enhance, stimulate, and evaluate participants' knowledge. These tools offer an engaging and enjoyable way for participants to acquire information and participate in the session. |
| Ensure participants use behavioural skills. | Assessing compliance through the MYMAAT questionnaire and monitoring HbA1c levels prove effective for behaviour change evaluation. By evaluating these measures before and after the intervention, researchers can acquire valuable insights into their effectiveness and confirm the desired behavioural changes have taken place. |