Effectiveness of Story-Centred Care Intervention Program in Older Persons Living in Long-term Care Facilities：A Randomised Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- 15-Item Geriatric Depression Scale
研究概览
简要总结
The study aim is to evaluate the effectiveness of Story-Centred Care Intervention Program on reducing depressive symptoms, improving cognitive function, HRV, Blood pressure and quality of life in older adults living in a long-term care facility.
详细描述
Design A single-blind two-group longitudinal experimental study will be conducted to compare a story-centred care intervention program with a health consultation control condition. After receiving informed consents, participants will be randomly assigned to one of the two treatment conditions, either a story-centred care intervention program or a health consultation control condition. Each intervention will be conducted for 4 weeks. Measurements will be obtained at the following time points: pre-intervention (baseline), post-intervention and 1-month- and 3-month follow-up (see Figure 1). Outcome measurements include the following parameters: 15-item geriatric depression scale test (GDS-15), short portable mental status questionnaire (SPMSQ) , WHO Quality of Life-BREF (WHOQOL-BREF), blood pressure and 5-minute HRV.
Recruitment Participants will be recruited from January 2013 to August 2013 via posters and notifications during routine activities and gatherings. The study design and protocols will be reviewed and approved by the institutional review board of the participating hospital. At the content session, all assessments and procedures will be fully explained. When participants express their interest in participating in the study, they need to leave their contact information at the front desk. The research team will contact the participants as soon as a list is compiled.
Assessment of eligibility and randomisation Participants will beconsidered eligible if they meet the inclusion criteria. All participants will be informed that they can withdraw themselves from the study at any time. Before randomisation, participants will be asked to answer a few questionnaires and will be subjected to the 5-minute HRV test. The questionnaires include demographic characteristics, the 15-item geriatric depression scale test (GDS-15) and SPMSQ. Randomisation will be conducted using a computer-generated randomisation scheme (SPSS software Version 21.0). Participants will be randomly assigned to the story-centred care intervention program or to the health consultation control condition. The random allocation sequence will be set in a uniform 1:1 allocation ratio.
Blinding Participants will be randomly assigned to either the story-centred care intervention program or the health consultation control condition. They will be informed not to disclose their randomisation status to anyone. The outcome evaluator will be blinded to the assigned condition of the participants.
Intervention Participants will randomly be assigned to the experimental (intervention) group (IG) or the control group (CG) using SPSS software (Version 21.0). Participants in the IG will receive the story-centred care intervention program once a week for 4 weeks; the CG will receive health consultation from researchers once a week for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- those who are ≥65 years old and live in long-term care facilities
- •- have clear consciousness and normal hearing and conversation capability
- •- are not taking any antidepressants at the time of the study
- •- are not clinically diagnosed with dementia or have an SPMSQ score of ≥5
- •- have not lost a loved one in the past 3 months and
排除标准
- •-meet DSM-IV criteria for Dementia of the Alzheimer's type
- •-suffer from moderate to severe cognitive impairment (SPMSQ > 5)
- •-are taking antidepressants at the time of the study
- •-are undergoing other psychotherapy during the study and
- •-have any underlying medical illness that could interfere with the treatment.
结局指标
主要结局
15-Item Geriatric Depression Scale
时间窗: Change from depressive symptoms at 4 months
次要结局
- The Short Portable Mental Status Questionnaire(Change from cognitive at 4 months)
- blood pressure(Change from blood pressure at 4 months)
- Heart rate variability(Change from HRV at 4 months)
- WHO quality of life-BREF(Change from quality of life at 4 months)
研究者
Fung-Wei Chang
Director, Head of Obstetrics and Gynecology, Clinical Professor
Tri-Service General Hospital