HED-Start: A Randomised Controlled Trial to Evaluate a Positive Skills Intervention for Patients New on Haemodialysis
试验速览
- 阶段
- 不适用
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change in Anxiety and Depression (HADS) scores from baseline
研究概览
简要总结
Hemodialysis patients often experience barriers and misperceptions that hinder adjustment to life on dialysis. This study seeks to explore a group-based intervention (titled HED-Start) developed to improve self-care and emotional wellbeing among incident hemodialysis patients.
详细描述
There are potentially modifiable psychosocial barriers and misperceptions about life on dialysis that hinder adjustment outcomes. It is hypothesized that these may include: poor understanding on what is needed or 'how to implement treatment principles', misperceptions related to disease and treatment, catastrophizing beliefs about impact of dialysis and low level of confidence on ability to manage treatment regime and renegotiate life roles as a "dialysis patient".
This study seeks to explore the feasibility and acceptability of implementing a two-arm parallel randomized controlled trial of a group-based intervention (titled HED-Start). HED-Start is specifically developed to reduce psychological distress and support self-care and self-management outcomes in incident hemodialysis patients.
Drawing on self-management and motivational interviewing principles paradigm, the HED-Start program aims to facilitate acquisition of skills and knowledge to support and improve self-care and emotional adjustment outcomes.
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 (Care Provider, Outcomes Assessor)
盲法说明
Care providers (dialysis nurses) and outcomes assessors (research staff conducting the baseline and follow-up questionnaires) will be blinded to participant allocation.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with end-stage kidney disease (ESKD) and established on hemodialysis with the National Kidney Foundation Singapore (NKF) for fewer than 90 days
- •At least 21 years old
- •Proficient in spoken and written English or Mandarin
排除标准
- •Unwilling or unable to give informed consent or refuse to be randomized
- •Have cognitive impairments or psychiatric conditions that preclude consent
- •Are currently involved in other intervention trials
- •Are failing on dialysis and approaching end of life (supportive/palliative care pathway)
研究组 & 干预措施
HED-Start Intervention arm
Participants assigned to the intervention arm will undergo 4 sessions of the HED-Start program. Each session is 2 hours long and will be conducted fortnightly.
干预措施: HED-Start (Behavioral)
Standard care arm
Participants assigned to the standard care arm will proceed with routine standard care.
结局指标
主要结局
Change in Anxiety and Depression (HADS) scores from baseline
时间窗: Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization
Hospital Anxiety and Depression Scale (HADS). The HADS comprises two subscales (anxiety; depression) and can be totaled to produce an overall scale score. Scores range from 0 to 21 for each subscale, and from 0 to 42 for the overall score. Higher scores are indicative of worse anxiety and depression symptoms.
次要结局
- Change in Illness Perception scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Positive and Negative Affect scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Self-Efficacy for Managing Chronic Disease 6-item Scale scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in kidney disease-related quality of life (KDQOL-SF) scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Quality of life (WHOQOL-BREF) scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Benefit finding in hemodialysis (BFS) scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Resilience scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
- Change in Health Education Impact Questionnaire scores from baseline(Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization)
研究者
Konstadina Griva
Associate Professor of Health Psychology and Behavioural Medicine
Nanyang Technological University