STAR Caregivers - Virtual Training and Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Change in Caregiver Burden
研究概览
简要总结
This study evaluates the effectiveness of a caregiver outreach, training, and support program for caregivers of people with dementia who are using antipsychotic medication to manage agitation/aggression. The Investigators will conduct a randomized trial of the caregiver program compared to a control group to measure differences in caregiver burden and discontinuation of antipsychotic medication use. The results will help in expanding access to and delivery of empirically supported behavioral health services for caregivers and people with dementia.
详细描述
Alzheimer's Disease and related dementias (ADRD) are debilitating conditions affecting more than 5 million Americans in 2014. With aging of the population it is projected that 8.4 million people will be diagnosed with ADRD over the next 15 years and health care costs attributable to ADRD are projected to be more than 1.2 trillion by 2050. Behavioral and Psychological Symptoms of Dementia (BPSD) (anxiety, agitation, depression) are common and often involve aggressive behavior towards family caregivers (CG) in response to unmet needs, discomfort, or frustration. BPSD are disturbing and frequently lead to caregivers seeking medication to control patient symptoms. Antipsychotic use in persons with dementia (PWD) more than doubles mortality risk; however, many caregivers are willing to accept those risks. The Choosing Wisely Guidelines from the American Psychiatric Association and American Geriatrics Society both recommend against prescribing antipsychotics as a first-line treatment for BPSD. STAR-Caregivers is an efficacious first-line behavioral treatment, endorsed by the Administration on Aging, that involves caregiver training to manage BPSD. However, the program has not been implemented widely - partly due to the cost of the programs, difficulty conducting outreach, and modality of training (in person with written materials). Adequate caregiver training and commensurate reduction in caregiver burden are the mediators (mechanisms) the Investigators will engage in this Stage III trial to reduce BPSD and discontinue antipsychotic medication use by PWD.
The STAR-Caregivers program is an education, training, and support intervention demonstrated efficacious in reducing BPSD. The original program involved 8 face-to-face, in-home training sessions and 4 follow-up phone calls. The condensed version involves 4 in-home sessions with 2 phone follow-ups.18 Neither of these is feasible from a payer perspective. The investigators propose to test a self-directed, remote version called STAR-virtual training and follow-up (STAR-VTF) that leverages secure email within the member portal at Kaiser Permanente Washington to improve access to training, fidelity to the STAR principles, and to lower the cost of the program.
The investigators propose a Stage III trial to ascertain the feasibility and acceptability of STAR-VTF in which (a) caregiver training materials are delivered electronically and learning is self-directed, (b) caregivers have one orientation phone visit with a social worker and (c) where caregivers receive ongoing support from a social worker via telephone and secure messaging in the web-based member portal. Investigators will compare outcomes in the STAR-VTF group to an attention control group (mailed material, links to websites, and generic secure messages).
The specific aims are:
Aim 1: Assess the feasibility and acceptability of conducting caregiver outreach, training, and support via social workers including: (1) willingness of caregivers to interact primarily through secure messaging (contact rates); and (2) willingness of caregivers to complete self-directed training (training completion rates).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Caregiver Burden
时间窗: Change from baseline caregiver burden at 6 months.
Self-reported caregiver burden assessed by the Disruption subscale on the Revised Memory and Behavior Problem Checklist (RMBPC) questionnaire. The range in subscale scores is 0 to 32 with higher scores representing a worse outcome.
次要结局
- Change in Caregiver Depression(6 months from baseline)
- Change in Caregiver Self-efficacy(Change from baseline caregiver mastery at 6 months.)
- Kingston Caregiver Stress Scale(6 months from baseline)
- Number of Caregivers Who Responded to Surveys at 8-weeks(8 weeks from baseline)
- Number of Caregivers Who Responded to Surveys at 6-months(6 months from baseline)
- Number of Dyads Who Complete STAR-C VTF Online Training(8 weeks from baseline)
- Number of Inpatient Visits Had by Patient With Dementia(End of follow-up (6 months))
- Number of Primary Care Visits Had by Patient With Dementia(End of follow-up (6 months))
- Number of Emergency Department Visits Had by Patient With Dementia(End of follow-up (6 months))
- Antipsychotic Prescription Fills Rate for Patient With Dementia(After 8 weeks in the study)
- Antipsychotic Prescription Refill Rate for Patient With Dementia(8 weeks after initial prescription)
- Dementia Severity Rating Scale (DSRS) - Memory(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Speech and Language(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Recognition of Family Members(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Orientation to Time(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Orientation to Place(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Ability to Make Decisions(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Social & Community Activity(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Home Activities & Responsibilities(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Personal Care - Cleanliness(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Eating(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Control of Urination and Bowels(6 months from baseline)
- Dementia Severity Rating Scale (DSRS) - Ability to Get From Place to Place(6 months from baseline)
