Statement of Fidelity Template
Intervention protocol fidelity will be assured through established methods outlined by the NIH Treatment Fidelity Workgroup on consistency in dose, providers, delivery, receipt and enactment of the intervention. [ Insert who will assure fidelity- ie Researcher, project staff...] will assure fidelity through maintenance of the protocol and its delivery. If questions or concerns arise regarding protocol fidelity, the respective expert will be consulted for assistance and advice.
Dose Consistency: [Insert intervention dose. This can be in form of time. Provide clear explanation of how the dosing will remain consistent throughout the duration of the study.] See example below.
Initially all patients will have four weeks of either reflexology or meditative practices with their caregiver. Weekly sessions for each of the two therapies will be approximately 45-60 minutes long. Thirty-six days are allowed for the first 4 weekly sessions, providing a maximum interval of nine days in between. Symptom data from the first four weeks will then be evaluated to determine which therapy the dyads will continue with through week 8.
Provider Consistency: [How will study providers and caregivers (if applicable) maintain consistency of the study protocol? Will they receive training? What is the minimum score needed on training to be a provider? Explain in detail.] See example below.
All study providers will pass a demonstration of > 90% proficiency as judged by the trainers’ score on the checklist for both therapies before beginning with caregivers. Caregivers must also achieve 90% accuracy.
Delivery Consistency: [How will intervention delivery remain consistent throughout the duration of the study? What training is required for study providers and caregivers (if applicable) to continue participating?] See example below.
There will be a QA check and booster session conducted biannually for each study provider (those who teach caregivers, one or both therapies), with a 90% proficiency in delivery of the therapies. Caregivers are taught and evaluated during intervention weeks 1 and 2. If taught the second therapy after week 4, training and evaluation occurs again at weeks 5 and 6.
Receipt and Enactment Consistency: [How will it be ensured/documented that participants consistently receive treatment/intervention according to study protocol?] See example below.
During weekly calls by the Education Coordinator, patients will have a symptom assessment. The caregiver will also be called by the Education Coordinator every seven days and asked the number of complete sessions since the last weekly call seven days ago. A minimum of 1 session is expected, but the exact number of sessions reported by the caregiver will be recorded weekly. Thus, fidelity of the receipt and enactment of both therapies will be documented weekly over the 8-week intervention period.