跳至主要内容
临床试验/NCT04945486
NCT04945486已完成不适用

The Effect of a Peer-mentor Intervention on Inequality in Cardiac Rehabilitation Attendance: a Mixed Method Intervention Study Among Older Vulnerable Patients With Ischemic Heart Disease

University College Copenhagen2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2021年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
117
试验地点
2
主要终点
Cardiac rehabilitation attendance

研究概览

简要总结

BACKGROUND: Advanced treatment regimens have reduced cardiovascular mortality resulting in an increasingly older Ischemic Heart Disease (IHD) population in need of cardiac rehabilitation (CR) , the majority (74%) is above 60 years. The positive effect of CR is well established; CR reduces cardiovascular mortality, lowers hospital admissions, and improves quality of life among patients with IHD. These positive effects of CR has also been established among older patients. The inherent problem lies in the low attendance rate, often below 50%. Several studies, including studies from Denmark, have shown that low participation in CR is most prevalent among older, vulnerable and female patients. The notion vulnerable covers patients with low socioeconomic position (SEP), patients with non-western background and patients living alone, as these groups have particularly low CR attendance. Effective interventions aiming at increasing CR attendance among these low attending groups are thus warranted and the current study will seek to address this.

AIM: To test the effect of a peer-mentor intervention among older vulnerable IHD patients.

DESIGN AND METHODS: The study is designed as a two arm RCT-study applying mixed methods.

Power calculations were based upon primary outcome 'Cardiac rehabilitation (CR) attendance'. Proportion attending CR in control group was set at 25% and intervention group at 50% based upon previous research. With a 5% significance level and 80% power. 110 patients were required (55 in each group) to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure from 25% in the control group to 50% in the experimental group.

Expected dropout was 6%. I.e., in total 117 patients are enrolled.

Patients (n=117) are recruited by a dedicated research nurse before discharge from the cardiology department at Nordsjællands Hospital and randomized (with 1:1 individual randomisation) to peer-mentor intervention or usual care. Data is collected through both qualitative and quantitative data (mixed methods). Data is collected at three timepoints, baseline, 12 weeks and 24 weeks. The patients (mentees) are matched with peer-mentors. Peer-mentoring (i.e. mentoring by a person with a similar life situation or health problem as one self) is a low-cost intervention that holds the potential to improve CR attendance and improve physical and psychological outcomes among older patients. Peer-mentors are role models who can guide and support patients overcoming barriers of CR attendance. Peer-mentoring is unexplored in a CR setting among older, female and vulnerable IHD patients; establishing the novelty of the current study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Masking is not possible

入排标准

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

入选标准

  • ≥65 years and diagnosed with IHD and referred to CR and female or low SEP or single living or non-western background

排除标准

  • Patients unable to provide written consent

结局指标

主要结局

Cardiac rehabilitation attendance

时间窗: 24 weeks

Measured as 'self-reported CR attendance'

次要结局

  • Qualitative content of disease trajectory(Baseline to 24 weeks)
  • Change in Self-efficacy(Baseline to 24 weeks)
  • Change in symptoms of anxiety and depression(Baseline to 24 weeks)
  • Change in Health-related Quality of Life(Baseline to 24 weeks)
  • Change in dietary quality(Baseline to 24 weeks)
  • Change in physical activity(Baseline to 24 weeks)

研究者

发起方
University College Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Kjøller Pedersen

Associate Professor

University College Copenhagen

研究点 (2)

Loading locations...

相似试验