The Effectiveness of a Value-based Emotion-focused Educational Programme to Reduce Diabetes-related Distress in Malay Adults With Type 2 Diabetes (VEMOFIT): a Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 主要终点
- Diabetes-related distress
研究概览
简要总结
The purpose of the clinical trial is to evaluate the effectiveness of a relatively simple and short value-based emotion-focused educational programme in adults with type 2 diabetes (VEMOFIT) on diabetes-related distress, depressive symptoms, illness perception, medication adherence, quality of life, diabetes self-efficacy, self-care and clinical outcomes.
详细描述
Type 2 diabetes (T2D) patients experience many psychosocial problems related to their diabetes, as well as social- and work-related relationships. These often lead to emotional disorders such as distress, stress, anxiety and depression. Without proper care, these patients use more often negative coping strategies and more frequently expect that their diabetes will negatively affect their future. A cluster randomised controlled trial will be conducted in 10 public health clinics (HC) in Malaysia. These clusters are eligible if they are providing standard diabetes care according to national clinical practice guidelines, not involved in similar trial and having nurses to be trained to deliver the VEMOFIT educational programmes. Pre-stratification by cluster size and geographic areas of the HCs will get randomised five HCs to the VEMOFIT group (VG) and attention-meetings group (AG), respectively.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malay patients
- •Diagnosed with T2D for at least two years
- •On regular follow-up with at least three visits in the past one year
- •Have diabetes-related distress (mean DDS-17 score ≥ 3)
- •Showing poor disease control (not reaching targets for one of the three biomarkers, namely HbA1c ≥ 8%, blood pressure ≥ 140/90 mmHg and LDL-C > 2.6 mmol/L)
排除标准
- •Patients who are enrolled in other clinical studies
- •Pregnant or lactating
- •Having psychiatric/ psychological disorders that could impair judgments and memory
- •Patients who cannot read or understand English or Malay
- •Patients who scored ≥ 20 on the Patient Health Questionnaire-9 (PHQ-9) that suggest a severe depression
研究组 & 干预措施
Attention-meetings (AG)
Attention-control
干预措施: Attention-meetings (AG) (Behavioral)
VEMOFIT (VG)
Personal value exploration, disease education, emotional skills and goal setting.
干预措施: VEMOFIT (Behavioral)
结局指标
主要结局
Diabetes-related distress
时间窗: 12-month [T3]
Measured with the 17-item Diabetes Distress Scale (DDS-17)
次要结局
- LDL-cholesterol(12-month [T3])
- Blood Pressure(6-month [T2])
- Positive emotions(12-month [T3])
- HbA1c(12-month [T3])
- Blood pressure(12-month [T3])
- Illness perception(12-month [T3])
- Self-care behaviours(12-month [T3])
- Quality of life(12-month [T3])
- Self-efficacy(12-month [T3])
- Depression(12-month [T3])
研究者
Boon-How Chew
Associate Professor
Universiti Putra Malaysia