跳至主要内容
临床试验/NCT07141108
NCT07141108招募中不适用

Egenmonitorering Och Distansmonitorering av långvarig smärta i primärvården, användandet av Ett Digitalt Verktyg för Att ökad livskvalité

Lund University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Evaluation of a Digital Self-Management Tool to Support Primary Care in Managing Persistent Pain

研究概览

简要总结

Chronic pain impacts individuals, their families, and society significantly, yet specialist care resources are limited, with most patients managed in primary care. There is a need for tools that support self-management and improve resource allocation. This feasibility study evaluates the implementation of Paindrainer®, a CE-marked Class I digital tool, in primary care. Paindrainer® combines patient self-monitoring via an app with a healthcare provider portal (CARE) for remote monitoring. Using advanced neural networks, it offers personalized feedback to help patients plan and monitor daily activities and their impact on pain. The study aims to assess whether integrating this tool can enhance chronic pain management and patient quality of life.

详细描述

Long-term pain causes significant suffering to the individual, their loved ones and also entails high societal costs. In specialist care, constant development is underway through the implementation of new research and clinical findings. Patients' own efforts, decisions and strategies are a central and effective part of today's pain management. The importance of strengthening communication between patient and healthcare professionals is increasingly emphasised, as well as promoting the patient's ability to self-manage their situation.

More recently, behavior-modifying techniques have been integrated as complementary measures in the treatment of chronic pain. Despite this, a challenge remains for the healthcare system to create long-term sustainable outcomes for people with chronic pain.

The proportion of people with long-term pain who currently receive treatment in specialist care is very small, and the majority are treated in primary care instead. Resources for this patient group are insufficient and there is a great need for new tools for self- and remote monitoring that could improve the allocation of resources for this group.

This feasibility study aims to investigate whether a digital remote monitoring tool, Paindrainer®, can be implemented in primary care. The tool contains two parts, an app for the patient to use for their own monitoring of activity levels and symptoms, and the CARE portal, which is a remote monitoring tool for healthcare. The study will further explore how the implementation of this digital app in the existing treatment strategy can help address these challenges and improve care for people with chronic pain.

Paindrainer® is a CE marked class 1 product according to MDR and is based on advanced neural networks, which enables sophisticated calculations and takes into account more variables that affect the individual's pain experience and function than the human brain can handle. By using advanced calculations, Paindrainer provides continuous feedback to the patient, giving them a tool to plan and monitor their activities and understand how they affect each other.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

  • •Has pain that affects daily life and has lasted for more than 3 months
  • •Is over 18 years old
  • •Understands Swedish or English
  • •Is motivated and willing to use a digital tool for self-monitoring of activity level and symptoms
  • •Has no planned surgeries during the study period
  • •Has knowledge of and access to using a smartphone or tablet

排除标准

  • •Severe or acute mental illness, severe anxiety, or depression
  • •Ongoing history of substance use disorder
  • •Serious illness under active treatment
  • •Pain related to malignancy
  • •Currently involved in legal proceedings or ongoing litigation related to low back or neck pain

研究组 & 干预措施

Digital pain management Intervention Group

Experimental

Participants in this arm will use the Paindrainer® digital tool as part of their pain management strategy in primary care. Paindrainer® consists of a mobile app for self-monitoring of activity levels and symptoms, and a CARE portal for healthcare providers to support remote monitoring. The tool uses advanced neural networks to provide personalized feedback to help individuals plan and balance daily activities, aiming to enhance self-management and patient-provider communication. Standard care in primary care will continue in parallel. The study will evaluate the feasibility of implementing Paindrainer® in primary care settings and its potential to support long-term management of persistent pain conditions.

干预措施: Paindrainer Care system (Device)

结局指标

主要结局

Evaluation of a Digital Self-Management Tool to Support Primary Care in Managing Persistent Pain

时间窗: 12 weeks

Through the use of logged daily activities the overall purpose of this study is to investigate how the digital tool Paindrainer® can support primary care in assisting individuals with persistent pain, reducing the impact of pain in daily life, and improving quality of life. The study focuses on evaluating the effectiveness and usability of Paindrainer® in supporting primary care efforts to provide adequate care, enhance continuity, and increase patient confidence in managing long-term pain conditions. The primary parameter to analyse is PROMSI Pain interference 6a and usability questioners

Evaluation of a Digital Self-Management Tool to Support Primary Care in Managing Persistent Pain

时间窗: 12 weeks

Through the use of logged daily activities the overall purpose of this study is to investigate how the digital tool Paindrainer® can support primary care in assisting individuals with persistent pain, reducing the impact of pain in daily life, and improving quality of life. The study focuses on evaluating the effectiveness and usability of Paindrainer® in supporting primary care efforts to provide adequate care, enhance continuity, and increase patient confidence in managing long-term pain conditions. The primary parameter to analyse is PROMSI Pain interference 6a and usability questioners

次要结局

  • Change in Health-Related Quality of Life measured by the PROMIS-29 Profile(From baseline to 12 weeks)
  • Change in Pain Acceptance(From baseline to 12 weeks)
  • Change in Pain Catastrophizing measured by the Pain Catastrophizing Scale (PCS)(From baseline to 12 weeks)
  • Change in Health-Related Quality of Life measured by the PROMIS-29 Profile(From baseline to 12 weeks)
  • Change in Pain Acceptance(From baseline to 12 weeks)
  • Change in Pain Catastrophizing measured by the Pain Catastrophizing Scale (PCS)(From baseline to 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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