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Journal Article
Randomized Controlled Trial
Patient-centered integrated healthcare improves quality of life in Parkinson's disease patients: a randomized controlled trial.
Journal of Neurology 2018 April
INTRODUCTION: Improving quality of life (QoL) is a key issue when dealing with Parkinson's disease (PD). Integrative care shows potential to achieve improvements in QoL. Here, we analyzed whether a community-based, open-label, integrated approach improves QoL in PD patients.
METHODS: PD patients were screened for eligibility and evaluated by a university-based PD specialist, a PD nurse, and a general neurologist at a local practice. Patients were randomly assigned to a control group (CG), receiving standard German neurological treatment including a baseline assessment and follow-up visit at 6 months, or an interventional group (IG) who received an individually tailored therapy plan and additional home visits. Patients and investigators were not blinded for either intervention. Primary outcome analysis compared the differential change of PDQ-39 from baseline to 6-month follow-up between CG and IG. Between-group changes in mood, motor/non-motor functioning, and cognition were secondary outcomes.
RESULTS: 300 patients were included and randomized equally to IG and CG. 132 IG and 125 CG patients had a valid PDQ-39 at follow-up and qualified for the modified ITT analysis. PDQ-39 improved more in IG compared to CG [2.2 points (95% CI - 4.4 to 0.1); p = 0.044]. Likewise, change scores between IG and CG favored IG for UPDRS III (p < 0.001, mean change 3.3, 95% CI - 4.9 to - 1.7) and PD-NMS (p < 0.001, mean change 11.3, 95% CI - 17.1 to - 5.5).
CONCLUSIONS: Data show that an integrated approach, compared to regular PD care, improves QoL as well as motor and nonmotor PD symptoms over 6 months. Future studies need to address the cost-benefit ratio and whether positive effects can be maintained beyond intervention.
METHODS: PD patients were screened for eligibility and evaluated by a university-based PD specialist, a PD nurse, and a general neurologist at a local practice. Patients were randomly assigned to a control group (CG), receiving standard German neurological treatment including a baseline assessment and follow-up visit at 6 months, or an interventional group (IG) who received an individually tailored therapy plan and additional home visits. Patients and investigators were not blinded for either intervention. Primary outcome analysis compared the differential change of PDQ-39 from baseline to 6-month follow-up between CG and IG. Between-group changes in mood, motor/non-motor functioning, and cognition were secondary outcomes.
RESULTS: 300 patients were included and randomized equally to IG and CG. 132 IG and 125 CG patients had a valid PDQ-39 at follow-up and qualified for the modified ITT analysis. PDQ-39 improved more in IG compared to CG [2.2 points (95% CI - 4.4 to 0.1); p = 0.044]. Likewise, change scores between IG and CG favored IG for UPDRS III (p < 0.001, mean change 3.3, 95% CI - 4.9 to - 1.7) and PD-NMS (p < 0.001, mean change 11.3, 95% CI - 17.1 to - 5.5).
CONCLUSIONS: Data show that an integrated approach, compared to regular PD care, improves QoL as well as motor and nonmotor PD symptoms over 6 months. Future studies need to address the cost-benefit ratio and whether positive effects can be maintained beyond intervention.
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