Early Detection and Prevention of Lifestyle Related Diseases - Pilot2
试验速览
- 阶段
- 不适用
- 入组人数
- 4,800
- 试验地点
- 8
- 主要终点
- Participation (Consent)
研究概览
简要总结
A large proportion of the Danish population leads an unhealthy lifestyle. The associated surge in lifestyle-related disease (LRD) represents a significant health and economic burden for the individual as well as society. However, the reactive nature of the Danish national health-care system, complicates a comprehensive and concerted preventive response to this issue. The TOF project aims to remedy this situation by 1) Using digital support systems to systematically identify citizens at risk of LRD and 2) Target the preventive services at citizens with the highest need. Specifically, the ultimate goal of TOF is to integrate the clinical and municipal preventive primary health-care system into a targeted preventive service that facilitates lifestyle change in the at-risk population, and thus reduces LRD at a population level. To this end, we have developed a complex intervention in close collaboration with central stakeholders (health professionals, citizens). The initial feasibility of the intervention has been tested in a pilot study comprising two municipalities, 47 GPs, and 8814 citizens. The intervention has subsequently been adjusted in collaboration with the end users, focusing both on recruitment activities and implementation activities in general practice. The upcoming step involves testing of the adjusted intervention (Pilot2), before large-scale implementation and efficacy evaluation.
The feasibility, acceptability, and short-term effect of the adjusted intervention will be tested in two municipalities using quantitative as well as qualitative research methods. The evaluation will focus on the reach of the intervention, the implementation and acceptability of the intervention in general practice and municipality, the use and assessment of the digital support system and the possible short-term effects on patient lifestyle and risk of disease. We expect 15 general practitioners and 4800 patients to participate.
The intervention comprises four main components:
- Participants will be screened for LRD-risk factors by survey
- Survey information is linked with participants' medical history in order to stratify participants into designated risk groups
- Depending on risk level, participants will be offered targeted interventions at the GP or municipality.
- Throughout the intervention, a digital support system providing personalized feedback and advice (health profile) to participants will be accessible to both participants and health professionals.
详细描述
Two (Haderslev and Middelfart) of the seven municipalities participating in the large-scale TOF study volunteered to participate in Pilot2. In February-March 2018, GPs from these two municipalities will receive an invitation to participate. The target group of Pilot2 comprises 4.800 adults born between 1959 and 1988 and who are registered with a participating GP.
Prior to study commencement, all enrolled GPs, practice nurses (PN), and health professionals from the municipalities are invited to a joint kick-off meeting. The meeting will focus on the intervention activities and tasks assigned to the GP clinics and the municipality. In addition, all GP practices will be offered an introductory visit from the project secretariat to help organize and plan project activities.
In October 2018 half of the target population will receive a mailed pre-notification (postcard), and 2 weeks later the full target population will receive an invitation, sent on behalf of the GP and the municipality to the individual's e-Boks. Two different invitations are tested; a) A broad invitation and b) an invitation targeting citizens with low educational attainment. Random selection is used to allocate citizens to the four invitation groups: (+/- postcard x Invitation a/b). To enroll in the study, citizens are asked to sign a consent form via a link to a secure, digital support system, accessible only with a two-phased NemID password. The consent form will outline study participation and disclosure of data from the GPs electronic patient record (EPR). Short videos on the digital support system will also be made available to participants. These videos come in different versions, designed for male and female participants, specifically. The main purpose of including the videos is to describe the purpose of the study and the intervention. To adjust for social inequality in health, proactive recruitment activities will be conducted by the participating municipalities in socially deprived areas.
Upon consent, information on relevant diagnoses (International Classification of Primary Care (ICPC-2) codes) and prescribed medicine (Anatomical Therapeutic Chemical Classification (ATC) codes incl. text fields with indication for treatment) are collected from the GPs' EPR systems.
Five months after consent (April 2019), participants will receive another digital invitation in their e-Boks, this time to fill in a questionnaire and access their personal health profile. Participants can opt out at any time during the intervention period by clicking an "opt-out" button on the digital support system.
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
- 29 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •GP affiliation: Patients affiliated to one of the participating GPs
- •Year of birth: 1959-1988
- •Place of recidence: Municipalities of Haderslev or Middelfart
排除标准
- •Patients invited to participate in TOFpilot1
- •No access to digital mail (e-Boks)
研究组 & 干预措施
Lifestyle intervention
The intervention group comprises ~4800 patients born 1959-1988, living in the municipalities of Haderslev or Middelfart, and affiliated to one of the participating GPs. No control group is included.
干预措施: Lifestyle intervention (Behavioral)
结局指标
主要结局
Participation (Consent)
时间窗: From initial invitation (consent) (October 2018) to deadline for consent (6 weeks later)
Participation (Consent) is defined as the proportion of citizens who following the initial invitation concents to take part in the study.
Participation (Personal Health Profile)
时间窗: From invitation to receive a personal health profile (April 2019) to deadline for receiving the personal health profile (4 months later)
Participation (Personal Health Profile) is defined as the proportion of consenting participants who receives a personale health profile.
Participation (Targeted intervention in General practice or Municipality)
时间窗: From second invitation (April 2019) to deadline for receiving the targeted interventions (4 months later)
Participation (Targeted intervention in General practice or Municipality) is defined as the proportion of participants (Personal Health Profile) who takes up the targeted intervention in general practice or municipality.
次要结局
- Patient reported self-efficacy before study commencement and at one year follow up(At consent and 1 year follow up)
- Patient reported mental well-being before study commencement, immediately after the study period and at one year follow up(At consent, immediately after the study period and at 1 year follow up)
- Uptake of targeted intervention against osteoarthritis (GLA:D)(From receipt of personal health profile (April 2019) to one year follow up)
- Change in patient health risk behaviour (lifestyle) from study commencement to 12 months follow up(From receipt of personal health profile (April 2019) to one year follow up)
- Qualitative evaluation of the digital support system with focus on experienced usefulness(Observations will be conducted during full working days at the municipal health centers and in general practice. Interviews will be of approximately 30 minutes duration.)
- Qualitative process evaluation focusing on the intervention in general practice(Observations will be conducted during the health checks (10 minutes) and the health dialogues (30 minutes). The subsequent interviews will be of up to 30 minutes duration.)
- Qualitative process evaluation focusing on the intervention in the municipality(The semistructured individual interviews will be of up to 30 minutes duration. The focus group interviews will be of up to 2 hours duration.)
- Patients' perceptions of relational empathy following the health dialogue at the GP and municipality(Immediately following each health dialogue)
- Participants social network before study commencement and at one year follow up(At consent and 1 year follow up)
- Perceived social network norms before study commencement and at one year follow up(At consent and 1 year follow up)
- Osteoarthritis risk factors at study commencement and one year follow up(From receipt of personal health profile (April 2019) to one year follow up)
- Change in proportion of patients at increased risk of CVD from study commencement to 12 months follow up(From receipt of personal health profile (April 2019) to one year follow up)
- Patients perception of the shared decision making proces during health consultations(Immediately following each health dialogue)
- Change in proportion of patients at increased risk of diabetes from study commencement to 12 months follow up(From receipt of personal health profile (April 2019) to one year follow up)
- Change in proportion of patients at increased risk of COPD from study commencement to 12 months follow up(From receipt of personal health profile (April 2019) to one year follow up)
- Health professionals perception of the shared decision making proces during health consultations(Immediately following each health dialogue)
- Patient reported meaning-making(At consent and at one year follow up)
- Patient reported spiritual wellbeing(At consent and at one year follow up)
- Patient reported religious belief and practices(At consent and at one year follow up)