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Please see Appendix A for a copy of the session checklist.
The session checklist included education on insulin action, injection sites, the pen device, and hypoglycemia awareness and treatment.
To ensure fidelity of intervention delivery, the intervention protocol was detailed in a manual, all sessions were scripted and all intervention calls were audio-taped and reviewed against a session checklist based on the objectives for each session.
During the course of the study, clinicians complete a session checklist at the conclusion of each session with a client, which outlines the focus and content of the session, including whether or not SHADE or other technologies were used.
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Session checklists will be used to monitor the content delivered.
Assuming a 50% compliance rate with completion of session checklists by clinicians, we estimate having a pool of 342 session checklists for analysis.
Clinicians will also complete session checklists following each clinical session with a client, outlining the extent to which the SHADE computer program was used.
Fidelity to treatment protocols in both arms will be ensured by: a) having therapists submit a completed checklist following each session; b) regular review of submitted session checklists; c) therapist participation in monthly group supervision; and d) recording of therapy sessions.
(5) Completion of session checklists (see Appendix A) following every counselling session with new and ongoing clients, regardless of their exposure to the SHADE treatment program, and therapeutic alliance measures at intake and discharge for all clients.
On each occasion, mentors completed a session adherence checklist (see online supplementary appendix 1).
Treatment fidelity is enhanced through use of treatment manuals, session implementation checklists, audiotaping and rating of randomly selected sessions, one-on-one supervision and bi-weekly group debriefing sessions involving structured case presentations and review of treatment documentation.
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