Statistical analysis
T-tests and chi-square tests were used to determine if randomization achieved balance between the two arms. Generalized estimating equations (GEE) with an unstructured covariance matrix and Gaussian distribution examined differences in change over time (baseline, immediate post intervention/usual care and 12-months) between the two groups. There was little attrition over time (5 people for 98.3% retention) so no replacement of missing data was used. GEE does not require complete data at all time points, so all observations are included in the analyses. In this manuscript, we are reporting on 12-month follow-up data.