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临床试验/NCT03950713
NCT03950713已完成不适用

Taiwanese Mindfulness Program for Long Term Residents With Type 2 Diabetes

Fooyin University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
HbA1c values

研究概览

简要总结

This study aimed to evaluate the effectiveness of the newly developed Mindfulness-Based Stress Reduction-Taiwan program (MBSR-T) for old people with type 2 diabetes living in long-term care facilities.

详细描述

This study reported the first randomized controlled trial of Mindfulness-based reduction stress for residents with type 2 diabetes newly moved into long-term care facilities on depression, relocation stress and HbA1c levels. The results highlighted the benefits of using strategies in the MBSR-T to promote good quality of diabetes care for residents in long-term care.

The contents of the 9-week MBSR-T program were adapted from an initial MBSR program by the Taiwan Mindfulness Association for older people with diabetes (Chinese version). The program consisted of a 1.5-hour session each week for 9-weeks for a group of 8 to 10 participants. Each session included 30 minutes of mindful deep breathing relaxation and 60 minutes of practicing mindfulness activities.

A total sample of 140 was determined. All eligible individuals in each long-term care facility were randomized by computerized random numbers, sequence generated by an independent statistician with one-to-one ratio for allocating to either control or intervention group. All participants were blinded to group allocation. Participants in the control group received usual care, while participants in the intervention group received the MBSR-T in addition to the usual care. All sessions in the MBSR-T were delivered by a trained mindfulness registered nurse who had received additional trainer qualification of mindfulness. A research assistant was blinded to the study protocol, who was employed to undertake data collection at baseline, at 3, 6, and 9 weeks (T0, T1, T2, T3).

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
None

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 65-85 years old
  • •Diagnosed with type 2 diabetes
  • •Moving into the facility within a year
  • •No obvious delirium, confusion or current psychiatric illness
  • •Being able to communicate in Chinese.

排除标准

  • •Terminally ill
  • •Unable to communicate in Chinese.

研究组 & 干预措施

Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)

Experimental

Participants in the intervention group received the MBSR-T in addition to routine care.

干预措施: Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T) (Behavioral)

Routine care

No Intervention

The control group received the routine care provided in facilities, including routine check-ups at diabetes clinics as necessary.

结局指标

主要结局

HbA1c values

时间窗: Change from baseline HbA1c values at 12 weeks

Glycemic control was measured by HbA1c values, and data were collected from participants' medical records.

次要结局

  • Relocation Stress Scale(Change from baseline relocation stress mean scores at 9 weeks)
  • Depression and Anxiety Stress Scale (DASS-21)(Change from baseline depression and anxiety stress mean scores at 9 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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