Health and Life in Balance an Intervention to Improve Patient Capacity for Older People With Multimorbidity: A Pragmatic Mixed Methods Non-randomised Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Illness Intrusivenss Rating Scale
研究概览
简要总结
The aim of this study was to examine if the intervention "Health and Life in Balance", was acceptable, feasible and if the intervention needed further development.
Health and Life in Balance is an intervention for patients 65 years and older, with 2 or more chronic diseases, and an increased care need. It involved for the patient to meet with a district nurse during 1-2 meetings to set up a care plan and then have scheduled follow-ups during 6 months. During the 1-2 meetings they went through ICAN discussion aid to discuss aspects of capacity and workload in the patient's life and healthcare. The district nurse and the patient's GP had improved communication during the intervention period.
Researchers will collect data from the patient's medical records, from questionnaires and from interviews with patients and health care providers.
Data will be analysed using both quantitative and qualitative methodologies and finally a mixed methods approach.
No drugs or devices are included in this study.
详细描述
Patients with multimorbidity, having more than one chronic disease, becomes more and more common as the world's population ages. However, primary care, often focusing on treating one disease at a time in short visits, show poor results in meeting these patients' needs. Hence, primary care needs to become more person-centered to meet patients with multimorbidity's needs.
In this study Health and Life in Balance, a complex intervention to improve relational continuity, person centeredness, and teamwork between the patient's district nurse and GP was piloted. The aim of the intervention was to improve patients with multimorbidity's capacity.
The aim of this study was to assess acceptability, feasibilty and need of further development of the intervention.
The study design was convergent mixed methods non randomised pilot study.
The research questions were:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
It is not possible to mask participating patients and health care providers. To avoid contamination we included one intervention and one control unit. In a potentially future RCT we aim to keep the cluster-design.
In a potential future trial we aim mask outcome assessors, and researchers handling data analyses.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years and older
- •2 or more chronic diseases
- •Increased care need defined by patient's GP
排除标准
- •home health care,
- •on-going treatment in a secondary unit making them unable to assimilate the intervention, for example ongoing oncological treatment,
- •cognitive impairment that restricted ability to give informed consent.
研究组 & 干预措施
Intervention Unit
23 participating patients in the intervention unit. These patients had the intervention Health and Life in Balance during 6 months. The intervention did not include the use of drugs or devices.
干预措施: Health and Life in Balance (Other)
Control Unit
29 participating patients in the control unit. These patients had care as usual.
干预措施: Care as usual (Other)
结局指标
主要结局
Illness Intrusivenss Rating Scale
时间窗: From enrollment to the end of the treatment at 6 months.
13 items scored 1 - 7 to a total of 13 (not very intrusive) to 91 (very intrusive)
次要结局
- EQ-5D-5L - EuroQol -5 Dimensions- 5L(From enrollment to the end of the treatment at 6 months.)
- Multimorbidty Treatment Burden Questionnaire(From enrollment to the end of the treatment at 6 months.)
- PHQ-9 - The Patient Health Questionnaire(From enrollment to the end of the treatment at 6 months.)
- PSWQ - The Penn State Worry Questionnaire(From enrollment to the end of the treatment at 6 months.)
- WHODAS 2.0 - WHO Disability Assessment Schedule(From enrollment to the end of the treatment at 6 months.)
- AUDIT - The Alcohol Use Disorders Identification Test, 12-item version(From enrollment to the end of the treatment at 6 months.)
- DUDIT - The Drug Use Disorders Identification Test(From enrollment to the end of the treatment at 6 months.)
- Number of medications(From enrollment to the end of the treatment at 6 months.)
- Number of visits in primary care (apart from the intervention)(Collected post-intervention (up to 1 year))
- Number of admissions to hospitals(Collected post-intervention (up to 1 year))