Process Evaluation of a Randomized Controlled Trial Studying the Effect of Music Therapy in Patients with Huntington ’ s Disease

Background/Introduction: This article reports the process evaluation of a multi-center randomized controlled trial in which the effect of music therapy in Huntington’s Disease (HD) was studied. The beneficial affects of this complex intervention, recorded in many, mainly qualitative case reports and studies, could not be confirmed with the design and outcome measures used in the present study. To find possible explanations for this discrepancy, we performed a comprehensive process-evaluation. Aim: To evaluate the execution of this Randomized Controlled Trial (RCT) by collecting information regarding (1) the study population, (2) the intervention and (3) the outcome measures. The evaluation will result in recommendations for future studies regarding study population, implementation and adjustment of the intervention and appropriate study design. Method: A mixed model of qualitative and quantitative data was used. Qualitative data were analyzed following the guidelines of thematic analysis within the grounded theory and naturalistic inquiry. Quantitative data were derived from the evaluation forms and were accounted for in the analysis. Results: The experience of twenty professionals was evaluated using an online survey, questionnaires, interviews, observation forms and field notes. The most obvious barrier was the severe cognitive decline of the study population in combination with circumstances within the participating centers, and the assessment tools that might not have been sensitive enough for the set goals of the RCT. Conclusion: Performing a multi-center RCT studying the efficacy of music therapy with vulnerable patients in a long-term care facility is feasible, but challenging. No matter how complex the intervention and the study population, with the right study design, outcome measures and assessment tools, and with an unambiguous written protocol, and a continuous evaluation and monitoring throughout the whole study, barriers can be by-passed or avoided, and facilitators can be empowered. Suggestions are made for future research concerning the use of alternative designs (multiple single subject design study) and measurement tools (Goal Attainment Scale (GAS), Music Therapy Assessment Tool for Advanced HD (MATA HD).