Effects of the Life Story Questionnaire on Physical Therapy Participation in Patients With Dementia: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pittsburgh Rehabilitation Participation Scale
研究概览
简要总结
The goal of this clinical trial is to see the effect of life story questionnaire (LSQ) on physical therapy participation in patients with dementia. The main question[s] it aims to answer are:
- What is the effect of LSQ usage on physical therapy participation in people with dementia?
- What is the effect of LSQ usage on depression in people with dementia?
- What is the effect of LSQ usage on the quality of life in people with dementia? The researcher will compare these effects between the intervention group (usage of the Life Story Questionnaire) and the control group (no usage of the Life story questionnaire).
All Participants will receive Physical therapy treatment as usual. The life Story Questionnaire will be used in the intervention group during physical therapy treatment.
Life Story Questionnaire: It is developed by the Crisis Prevention Institute, which is a type of life story book for people with dementia. The LSQ allows caregivers to start conversations about topics that are important to each patient, can help establish rapport between the caregiver and patient.
详细描述
Background: Dementia is characterized by a progressive decline in cognitive function. Dementia disease prevalence is substantially increased among people aged 65 years or older, with a progressive decline in memory, thinking, language and learning capacity. Although physical exercise benefits dementia patients, participation in activities is exceedingly difficult due to communication and cognitive impairments. Several studies demonstrated that life story books usage improved quality of life, depression symptoms, moods and participation in activity in people with dementia. However, these studies did not evaluate the effect of Life Story Questionnaire (LSQ) - a type of life story book - on physical therapy participation, depression symptoms, quality of life.
Objectives: To evaluate the impact of LSQ on (1) participation in physical therapy using Pittsburgh Rehabilitation Participation Scale; (2) quality of life using Quality of Life - Alzheimer's Disease Scale (participant's version); and (3) depression symptoms using Cornell Scale for Depression in Dementia (CSDD).
Methods: A consecutive sample of convenience of up to 60 patients with mild to moderate cognitive impairment with 44 (22 per group) completing the study will be recruited from a nursing home facility. Patients will be randomly allocated in two groups: (1) Control group, which will receive standard physical therapy care without LSQ use; and (2) Experimental group, where physical therapists will use the LSQ. Each patient's family member will receive a LSQ to complete prior to the start of the intervention. Patients' participation, quality of life and depression symptoms will be measured on day 1 and again after 3 weeks (mid-term), and 6 weeks of intervention. Quality of life and depression symptoms will also be measured 6 weeks following intervention. A licensed occupational therapist blinded to the participants' group allocation will measure all three dependent variables
Statistical Analysis
Descriptive statistics including means, standard deviations, frequency counts, median, mode, variance and frequency counts will be used to assess sample demographics. The Rank Sum test will be used to assess differences in Pittsburgh Rehabilitation Participation Scale between the intervention and control group. Spearman Rank correlations will be used to determine the strength of the correlation between Mini-Mental state examination, Pittsburgh Rehabilitation Participation Scale and Quality of Life Alzheimer Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The outcome assessor will be blind to the usage of the life story questionnaire for study participants. Additionally, the participants will not be told the group they were allocated to.
入排标准
- 年龄范围
- 60 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients residing at dementia facility in Texas;
- •Age 60-89 years;
- •Diagnosis of dementia disease, in mild to the moderate stage using the Mini-Mental State Examination (score between 10 -24) and
- •Attendance to physical therapy for 6 weeks.
排除标准
- •Unable to speak English;
- •Mini-Mental State Examination score >24 and
- •history of major psychiatric disorders such as schizophrenia and bipolar disorder requiring hospital admission within the last year.
结局指标
主要结局
Pittsburgh Rehabilitation Participation Scale
时间窗: 6th week of Physical Therapy
To measure participation in physical therapy. Participation is graded as none (1), Poor (2), Fair (3), Good (4), Very good (5), and Excellent (6). Higher score indicates greater participation in physical therapy sessions.
次要结局
- Quality of life - Alzheimer's disease - participant's version(6 weeks following intervention of Physical Therapy)
- Quality of life in Alzheimer's disease scale- participant's version(6th week of Physical Therapy)
研究者
Jean Michel Brismee
Principal co-investigator
Texas Tech University Health Sciences Center