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临床试验/NCT05234281
NCT05234281Unknown不适用

Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Mixed Anxiety Depression, Diabetes Mellitus Type 2, Low Back Pain, Chronic Obstructive Pulmonary Disease and Post COVID-19 Fatigue)

Helse i Hardanger2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
2
主要终点
Completion rates

研究概览

简要总结

The health care is faced by a growing challenge in the years to come: increasing age and chronic morbidity raising the costs, combined with decreased work participation. Among the conditions on the rise, we find anxiety/depression, musculoskeletal conditions, type 2 diabetes and chronic obstructive pulmonary disease. Recently, the rise of the Corona pandemic has yielded another group of (primarily young) patients with decreased work capacity, the post-Covid syndrome sufferers.

The aim of the present study is to establish, describe and summarize the experiences with a novel approach to rehabilitation for five of the most costly conditions; 1) low back pain, 2) chronic obstructive pulmonary disease, 3) type 2 diabetes mellitus, 4) mixed anxiety/depression and 5) post-Covid fatigue.

The concentrated interdisciplinary rehabilitation is characterised by three phases;

  1. Pre-intervention preparation (1-2 months): with the aim to mobilize the patients' resources for change
  2. Concentrated group intervention (2-5 days): interdisciplinary team - individually tailored training (further described below)
  3. Post-intervention follow-up (1 year): digital follow-up with the aim of integrate the changes into everyday living

The concentrated intervention:

The core intervention is based on trans-diagnostic features of the highly successful 4-day intervention for Obsessive Compulsive Disorder, namely:

  • Initiate treatment when the patient is ready for change
  • Focus on the behavioral patterns which maintain the disorder and help the patient to identify situations where they can choose to break the pattern ("micro-choices").
  • Assist the patient when they practice breaking the patterns. This may pertain to how they do physical training or to the way they walk, sit, eat, talk, take their medication and sleep, or to how they engage in social activities or take care of others.
  • Use long sessions to ensure that they face a broad range of potential micro-choices
  • Work side-by side with others going through an analogous pattern of change
  • Prepare them for taking responsibility for integrating the change into every-day living

Main outcomes will be

  1. Completion rates
  2. Patient satisfaction
  3. Changes to perception of illness
  4. Patient activation

Secondary outcomes will be

  1. Level of functioning
  2. Qualitative description of participants' experiences

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Competent to consent
  • Motivated to participate throughout the project
  • Digital competence

排除标准

  • Medical conditions that could preclude proper participation
  • Unable to take care of everyday needs (nursing requirements)
  • Cognitive failure

结局指标

主要结局

Completion rates

时间窗: 12 months

Percentage of participants who are eligible for participation, who complete the 1 year programme

Patient satisfaction

时间窗: 1 week post treatment and 12 months

The Client Satisfaction Questionnaire (CSQ-8) is an 8-item questionnaire that measures patient satisfaction with health services, where the items are rated from 1 (very low satisfaction) to 4 (very high satisfaction). The total score ranges from 8-32, with higher scores indicating higher degree of satisfaction. The CSQ-8 has good psychometric properties, with high internal consistency (Cronbach's α = .93), and high inter-item correlation.

Changes in level of patient activation

时间窗: Baseline, 3, 6 and 12 months

Changes (absolute levels and %) in patient activation before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire Patient Activation Measure (PAM-13). This is the shortened version developed by Hibbard et al in 2005. Each question replied categorically as either disagree strongly, disagree, agree, agree strongly or N/A. These are further scored and summarized, yielding a 0-100 score, where higher score indicates higher degree of patient activation. The questionnaire is widely used, with high internal consistency (Cronbach's α = .91).

Changes to cognitive and emotional perception of illness

时间窗: Baseline, 3, 6 and 12 months

Changes (absolute levels and %) in cognitive and emotional representations of illness before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire The Brief Illness Perception Questionnaire (Brief IPQ). This is a 9-item questionnaire designed to assess cognitive and emotional representations of illness. Questions are graded from 1 to 10. The last item deals with perceived cause of illness, in which respondents list the perceived three most important causal factors in their illness. For this questionnaire, the general word 'illness' can be replaced by the name of a particular illness. The word 'treatment' in the treatment control item can be replaced by a particular treatment such as 'surgery' or 'physiotherapy'.

次要结局

  • Changes in level of functioning(Baseline, 3, 6 and 12 months)

研究者

发起方
Helse i Hardanger
申办方类型
Other
责任方
Sponsor

研究点 (2)

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