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临床试验/NCT02747745
NCT02747745Unknown不适用

Theoretical Based Case Management Intervention for Dementia Family Caregivers

Chang Gung University2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
152
试验地点
2
主要终点
The Change of FCG Quality of Life

研究概览

简要总结

The growing number of persons with dementia (PWDs) calls for policy changes and service innovation. Recent case management (CM) research is recognized by its positive impacts on family caregivers (FCGs) of PWDs. However, research gaps are identified, including the paucity of theoretical based CM practice and a lack of mediator effects. Therefore, the original purpose of this five-year project was to implement a theoretical-based randomized controlled CM intervention for FCGs of early to moderate PWDs at home based on a stress model and tailor to needs prioritized by FCGs. This project was funded by the Minister of Scientific and Technology for the first two years and accomplished the first two aims: 1. First year: to develop and test the psychometric properties of related instruments and protocol (cross-sectional study); 2. Second year: to conduct a feasibility test for the CM intervention (a pilot RCT). The purpose of the current project is to achieve aim 3 (three years): to implement a 4-month CM intervention (the main RCT). In total, there will be 2 home visits, 2 phone calls to the dyads, and receiving telephone calls from the FCGs during the working hours. Investigator will collect 4-time point data at T0 for base line data, T1 (after the recruitment, 4 th month, the first follow up), T2 (after the recruitment, 6th month, the second follow up) and T3 (after the recruitment,12 th month). Investigator will recruit 76 dyads in three years (38 dyads for each group)(n = 152 in total). The primary outcomes are FCG QoL and PWD behavioral problems, while the secondary outcome is the percentages of PWD status (i.g. nursing home admission) and the frequency of PWD acute hospitalization. Investigator will also test of mediator effect of FCG self efficacy using statistical analysis method such as Hierarchical Linear Modeling (HLM).

详细描述

The primary care physicians in the memory disorder clinics at the participating hospitals (Chang-Gung Memorial Hospital at Lin-Kuo, Chang-Gung Memorial Hospital-Taoyuan branch, Catholic Mercy Hospital at Hukou, Hsinchu county) will receive a written letter to explain the purpose of this project and the eligible criteria of PWDs and their FCGs. Debriefing can be provided upon request. Then the participating physicians will help to identify eligible dyads; while one trained research assistant (RA) is responsible for CM implementation (RA I), and the second RA (graduate students, RA II) will be responsible for data collection in each time point.

To increase the feasibility of this project, the inclusion criteria of PWDs are made to reflect the recruiting site reality, including: (1) age being older than 60 years old; (2) having a primary FCG or a secondary FCG who can provides sufficient information and assistant for the PWD; co-residence is not required; (3) PWDs are those with cognitive impairment confirmed by the primary or secondary FCG or participating neurologists. The exclusion criteria of PWDs include: (1) acute illnesses, impaired sensory symptoms (hearing loss and severe visual problems); (2) acute agitation which requires emergency treatment; (3) chronic alcohol abuse or use of drugs which possibly affect central nervous system functions; (4) presence of major psychiatric disorders within the last 2 years; (5) neurological or systemic illness (e.g. delirium, hypoxia, or unstable thyroid dysfunction); (6) no primary FCG or secondary FCG.

Investigator will screen for FCGs who report and meet the criteria of moderate levels of severity in the following risk areas (Table 1): depressive symptoms, burden, distress to problematic behaviors of PWDs and healthy behaviors. The definition of primary FCG include: (1) age 18 years old or greater; (2) at least providing the most assistance (4 hours a day) to their relatives with dementia for the past three months or those who conduct secondary care to their relatives, meaning that these FCGs supervise the hired care assistants or foreign helpers who actually take care of the patients; co-residency is not required for family caregivers. Exclusion criteria of family caregivers include: (1) documented cognitive or mental disorder, such as severe memory problems or major affective disorders; (2) hearing or visual impairments which are not properly corrected; (3) prescribed drugs known to impair or enhance attention, e.g., antidepressants, barbiturates, or other depressants, amphetamines; (4) insufficient command of Mandarin, Taiwanese; (5) participation in other interventions which may contaminate the results of this study.

In previous project, the satisfactory level of our case management training course was high. All the trainees had the highest regard toward the professional quality of the content and the instructors (Chiu et al, 2013). One of the case managers served as research assistant in the previous project and will continue to work with us as interventionist upon funded. Investigator will conduct a three-year RCT involving repeated measures at four time points: baseline screening (T0), 4th month (the end of the intervention, T1), 6th month (post-treatment follow up, T2), 12th month (T3).

Randomization Randomization takes place after baseline assessment. An external independent person establishes the random order using random number tables.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age being older than 60 years old;
  • having a primary FCG or a secondary FCG who can provides sufficient information and assistant for the PWD; co-residence is not required;
  • PWDs are those with cognitive impairment confirmed by the primary or secondary FCG or participating neurologists

排除标准

  • acute illnesses, impaired sensory symptoms (hearing loss and severe visual problems);
  • acute agitation which requires emergency treatment;
  • chronic alcohol abuse or use of drugs which possibly affect central nervous system functions;
  • presence of major psychiatric disorders within the last 2 years;
  • neurological or systemic illness (e.g. delirium, hypoxia, or unstable thyroid dysfunction);
  • no primary FCG or secondary FCG.

结局指标

主要结局

The Change of FCG Quality of Life

时间窗: The outcome data will be collected after the recruitment in the 4th month (T1), 6th month (T2) and 12th moth (T3) either by home visits or dementia center or memory clinic visits.

The FCG QoL will be measured by the composite score of the measures from the 4 risk areas of FCGs for PWDs using The Center for Epidemiologic Depression (CESD-10), Chinese Caregiving Burden Scale (CBS), Neuropsychological Inventory (NPI) caregiver distress scale, and Health Promotion Profile.

次要结局

  • Yielding to FCG role (the PWD status)(The outcome data will be collected after the recruitment in the 4th month (T1), 6th month (T2) and 12th moth (T3) either by home visits or dementia center or memory clinic visits.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Chien, Chiu

Associate Professor

Chang Gung University

研究点 (2)

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