跳至主要内容
临床试验/NCT05519280
NCT05519280已完成不适用

Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors With Disabilities: A Randomized Controlled Trial

Mackay Medical College1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Change in quality of life summary scores before intervention to 4-week post intervention.

研究概览

简要总结

This study aimed to evaluate the effects of a biopsychosocial-spiritual (BPS-S) Group intervention on quality of life among seniors with disabilities in long-term care residential settings.

详细描述

Background: Traditionally, biomedical care approach has been insufficient to meet the complex needs of older people living with multi-morbidity. Promoting whole-person wellness and better quality of life becomes a key goal of care in residential long-term care facilities. The integrative approaches composed of physio-psycho-social and spiritual components might be a viable strategy to assist older adults accept uncontrollable life changes and enhance holistic wellness.

Purpose: The study purpose was to develop and evaluate the effects of 8-week biopsychosocial-spiritual (BPS-S) group intervention versus usual care on self-perception of quality of life (QoL) and meaning in life among seniors with disability in residential care home at mid- and post-intervention, and at a 1-month follow up.

Methods: This single-blind randomized controlled trail with repeated measures design was conducted in residential long-term care facilities. Both the experimental groups (EG) and the control group (CG) received routing group activities based on their institution's schedule. Additionally, the EG received 8 sessions of weekly BPS-S group therapy for 80 minutes each. The baseline characteristics of residents with disabilities (including demographic information, length of stay in the institution and medical conditions) were collected using a data sheet, and activities of daily living of these residents were measured using the Barthel Index. To evaluate the effectiveness of the BPS-S group therapy, the primary outcomes including "participants' overall QOL" and the secondary outcome "meaning in life" were assessed at four time points: before, mid- and post- intervention and at a 1-month follow up. Quality of Life Index (QLI)-Part I and Purpose in Life (PIL) test were used to measure these outcome variables, respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • being 65 years of age or older;
  • living in the institution for at least 1 month;
  • Barthel Index scores under 90;
  • no hearing, visual impairment and infectious diseases;
  • being able to follow instructions and participate in group activities.

排除标准

  • have the diagnosis of major depression.

结局指标

主要结局

Change in quality of life summary scores before intervention to 4-week post intervention.

时间窗: The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).

Quality of life was measured using the Chinese version of the Quality of Life Index (QLI)-Part I. It contains 33 items measuring satisfaction regarding the four domains (health and functioning, social and economic domain, psychological/spiritual wellness, and family). The QLI-Part I is a six-point satisfaction rating scale from very unsatisfied (1) to very satisfied (6). To determine the scores, each satisfaction item is recoded from -0.25 to 0.25, and both the overall and subscale scores of the QLI-Part I calculated by following step by step scoring instructions ranges from 0 to 30; highest values represent better quality of life

次要结局

  • Change in Meaning in life summary scores before intervention to 4-week post intervention.(The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).)

研究者

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

Chin-Tsung Shen

The Office of Research and Development

Mackay Medical College

研究点 (1)

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