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    【ChiCTR2200065417】Home-based dyadic mindfulness yoga programme for patients with Parkinson's disease and their caregivers

    基本信息
    登记号

    ChiCTR2200065417

    试验状态

    尚未开始

    药物名称

    /

    药物类型

    /

    规范名称

    /

    首次公示信息日的期

    2022-11-04

    临床申请受理号

    /

    靶点

    /

    适应症

    Parkinson's disease

    试验通俗题目

    Home-based dyadic mindfulness yoga programme for patients with Parkinson's disease and their caregivers

    试验专业题目

    A home-based dyadic mindfulness yoga programme for patients with moderate-advanced Parkinson’s disease and their family caregivers: a feasibility trial

    申办单位信息
    申请人联系人
    申请人名称
    联系人邮箱
    联系人邮编

    联系人通讯地址
    临床试验信息
    试验目的

    1) To examine the feasibility and preliminary effects of a dyadic mindfulness yoga programme compared with usual care on the primary outcome (depression) and secondary outcomes (anxiety, social support, mindfulness, functional balance, HRQOL, caregiver burden and PD-related motor and non-motor symptoms) among PwPD and caregivers at one week post-intervention (T1) and three month post-intervention. 2) To explore the experiences of Chinese PwPD and their family caregivers in using the dyadic mindfulness techniques for illness coping using a qualitative research approach.

    试验分类
    试验类型

    随机平行对照

    试验分期

    其它

    随机化

    After baseline assessment, dyads will be randomly assigned into one of the two groups on a 1:1 basis using the method of permuted block, with random block sizes between 4 and 8, and will be informed of their assigned group by an independent person not involved in assessment.

    盲法

    All outcome assessors will be blinded to subject allocation.

    试验项目经费来源

    Seed Fund for Basic Research

    试验范围

    /

    目标入组人数

    30

    实际入组人数

    /

    第一例入组时间

    2022-11-01

    试验终止时间

    2025-06-30

    是否属于一致性

    /

    入选标准

    We will recruit Chinese patients with idiopathic moderate-advanced PD (as indicated by the Hoehn and Yahr Scale stages III-IV: those with unilateral/bilateral symptoms, with/without postural instability who are able to walk or stand unassisted) and their family caregivers. For the patient, they need to be: 1. Aged between 50-80 years; 2. Experienced at least mild depressive symptoms–as indicated by a Patient Health Questionnaire-9 (PHQ-9) score >= 5 (15)–to ensure they are exposed to the core problem addressed by this study. As for the caregivers, they need to be self-identified as the primary co-residing caregivers of the patient counterparts for at least three months. Both of them need to be able to communicate in Cantonese. They will only be eligible if both the patient and caregiver in a dyad provide written consent to participate.；

    排除标准

    Exclusion criteria are: 1. Have been engaged in regular systematic mind-body practices such as Tai Chi, qigong, yoga or other forms of mindfulness training (> 2 times per week) in the past 3 months; 2. Have pre-existing acute psychotic disease; 3. Are currently participating in any other behavioural or pharmacological trial; 4. Have significant cognitive impairment as indicated by the Abbreviated Mental Test score <= 6; 5. Have other contraindication(s) that may limit their full participation (e.g., severe hearing or vision impairment, etc.).；

    研究者信息
    研究负责人姓名
    试验机构

    The University of Hong Kong

    研究负责人电话
    研究负责人邮箱
    研究负责人邮编

    /

    联系人通讯地址

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