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临床试验/NCT04278742
NCT04278742Unknown不适用

A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年12月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
240
试验地点
1
主要终点
Wound healing

研究概览

简要总结

Traditional directive style of requesting or demanding compliance to set behavior is found to have little effect on patient's self-care behavior. It is reported that patients prefer to restate or rephrase their understanding in a care setting, instead of a directive/didactic approach where the clinician provides 'one-way' information. In fact, directive persuasion is thought to lead to resistance to change and is counter-effective.

New approaches such as open ended communication, interview style and collaborative approach is found to engage patients better in their own care and elicit patient's own intrinsic motivations for making changes. One way to do this is to

  1. invite patient to share their thoughts or concerns then
  2. clarify patient's understanding

From their responses:

(3a) affirm patient's correct understanding or (3b) address misconceptions with permission.

In this study, the investigators will randomize 240 subjects into two groups: Group A will undergo the above describe collaborative approach to patient education and counselling; Group B will undergo current (traditional, didactic approach) patient education. It is hypothesized that the collaborative approach group (Group A) should experience better understand of their health condition and foot ulcer, be better able to adhere to treatment plan through collaborative participation and overall be more satisfied with the treatment. Outcomes will be tracked at (i) post intervention and (ii) 4 months post intervention.

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
Single (Participant)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed type II diabetes
  • Above age 21
  • Plantar foot ulcer - high risk with active full-thickness ulcer
  • Pedal pulses palpable or min toe pressure of 30mmHg
  • Medium of language: English
  • Activities of daily living (ADL) independent (without carer)

排除标准

  • Diagnosed mental health conditions
  • Diagnosed cognitive impairment
  • Diagnosed visual impairment
  • Diagnosed hearing and speech disabilities

结局指标

主要结局

Wound healing

时间窗: 12 weeks

Percentage patients with healed wound (wound size = 0cm)

次要结局

  • Knowledge score assessed by questionnaire(Week 1 and week 12)
  • Behaviour score assessed by questionnaire(Week 1 and week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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