To evaluate patient-reported health effects of an add-on structured goal-planning and supportive telephone follow-up rehabilitation program compared with traditional rehabilitation programs in patients with rheumatic diseases.
In this pragmatic stepped-wedge, cluster-randomized, controlled trial, 389 patients with rheumatic diseases recruited from 6 rehabilitation centers received either traditional rehabilitation or traditional rehabilitation extended with an add-on program tailored to individual needs. The add-on program comprised a self-management booklet, motivational interviewing in structured individualized goal planning, and 4 supportive follow-up phone calls after discharge. Data were collected by questionnaires on admission and discharge from rehabilitation stay, and at 6 months and 12 months after discharge. The primary outcome was health-related quality of life (HRQoL) measured by the Patient Generated Index (range 0-100, where 0 = low). Secondary outcomes included patient-reported health status, self-efficacy, pain, fatigue, global disease activity, and motivation for change. The main statistical analysis was a linear repeated measures mixed model performed on the intent-to-treat population using all available data.
A significant treatment effect of the add-on intervention on HRQoL was found on discharge (mean difference 3.32 [95% confidence interval 0.27, 6.37]; P = 0.03). No significant between-group differences were found after 6 or 12 months. Both groups showed positive changes in HRQoL following rehabilitation, which gradually declined, although the values remained at higher levels after 6 and 12 months compared with baseline values.
The add-on program enhanced the short-term effect of rehabilitation with respect to patient-specific HRQoL, but it did not prolong the effect as intended.