Diakonhjemmet Hospital, Oslo, Norway.
Hospital for Rheumatic Diseases, Lillehammer, Norway.
Arthritis Care Res (Hoboken). 2018 Nov;70(11):1576-1586. doi: 10.1002/acr.23520.
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.
评估附加结构化目标规划和支持性电话随访康复计划对风湿性疾病患者的患者报告健康效果与传统康复计划相比。
在这项实用的阶梯式楔形、集群随机、对照试验中,从 6 个康复中心招募的 389 名风湿性疾病患者接受了传统康复或传统康复加个体化需求附加计划。附加计划包括自我管理手册、结构化个体化目标规划中的动机访谈,以及出院后 4 次支持性随访电话。入院和康复期间出院时、出院后 6 个月和 12 个月通过问卷收集数据。主要结局是通过患者生成的指标(范围 0-100,其中 0=低)测量的与健康相关的生活质量(HRQoL)。次要结局包括患者报告的健康状况、自我效能、疼痛、疲劳、总体疾病活动度和改变的动机。主要统计分析是对意向治疗人群使用所有可用数据进行的线性重复测量混合模型。
附加干预对出院时 HRQoL 有显著的治疗效果(平均差异 3.32[95%置信区间 0.27,6.37];P=0.03)。在 6 个月或 12 个月后,组间未发现显著差异。两组在康复后 HRQoL 均表现出积极变化,尽管在 6 个月和 12 个月后,与基线值相比,数值仍保持在较高水平,但逐渐下降。
附加计划增强了患者特定 HRQoL 的短期康复效果,但未能如预期那样延长效果。