Lifestyle-Related Disorder Clinical Trial
Official title:
Early Detection and Prevention of Lifestyle Related Diseases - Pilot2
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:
1. Participants will be screened for LRD-risk factors by survey
2. Survey information is linked with participants' medical history in order to stratify
participants into designated risk groups
3. Depending on risk level, participants will be offered targeted interventions at the GP
or municipality.
4. 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.
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.
Intervention The intervention comprises a two-pronged approach: (1) A joint intervention that
applies to the entire sample, regardless of whether the participants are healthy, at risk, or
already in treatment for type 2 diabetes (T2DM), chronic obstructive pulmonary disease
(COPD), cardio vascular disease (CVD), hypercholesterolemia or hypertension; (2) A targeted
intervention that is offered only to participants who presumably would benefit from either
further examinations at the GP (high risk), or community health services, such as smoking
cessation, dietary advice, or physical activity (health-risk behavior).
The joint intervention consists of:
- Stratification to one of four risk groups. Stratification to a specific risk group is
determined by use of validated risk algorithms and EPR information.
- A digital support system with user interfaces for all users, including the patient, the
GP, and the municipal health professional.
- A personal health profile for all participating patients.
The targeted intervention consists of:
- A focused clinical examination and if necessary a subsequent health dialogue with a GP
(targeting patients at high risk), and / or
- A short telephone-based health dialogue with a municipal health professional. For
patients with limited capability to care for their own health, this initial talk may be
followed up with a subsequent face-to-face health dialogue (targeting patients with
health-risk behavior).
For all present intents and purposes, the term health dialogue refers to a consultation that
includes the elements of the 5As model and the techniques used in motivational interviewing.
The joint intervention All participants will have access to the digital support system, and
are invited to fill in a questionnaire, comprising 15 items on height, weight, self-perceived
health status, family history of LRD, COPD-related symptoms, smoking status, leisure activity
level, alcohol consumption, diet, and osteoarthritis risk factors. Questions about family
history of diabetes and leisure activity level were taken from the Danish Diabetes Risk
model. Similarly, questions on COPD-related symptoms and smoking status were derived from the
COPD-PS screener and the Heartscore BMI score. Items tapping dietary habits were from the
Swedish National Guidelines on Disease Prevention. The questionnaire takes approximately five
minutes to complete.
Based on the questionnaire and information from the individual EPR, participants are
stratified into four distinct risk groups:
- Group 1 - Participants with a pre-existing diagnosis and/or in current treatment for an
LRD.
- Group 2 - Participants at high risk of developing LRD, and thus eligible for the offer
of a targeted intervention at the GP.
- Group 3 - Participants engaging in health-risk behavior, and thus eligible for the offer
of a targeted intervention at the municipality.
- Group 4 - Participants with a healthy lifestyle and no need for further intervention.
Personal health profile Based on results of the stratification process, each patient receives
a personal health profile on the digital support system. The purpose of the health profile is
to encourage the patients to change their health-risk behavior and follow the tailored advice
provided by the system. Patients who are at increased risk of developing an LRD (Group 2) are
advised to consult their GP for further examination and advice. Similarly, patients engaging
in health-risk behavior (Group 3) are offered lifestyle counseling, or lifestyle courses in
the municipality. By definition, Group 4 patients lead a relatively healthy life with no need
for health-risk behavior change. Group 1 patients are advised to continue their treatment and
use the information provided to change health-risk behavior.
The personal health profile includes individualized information on current health-risk
behavior and risk of disease. The information is tailored based on the questionnaire, the
information from the EPR, and the risk scores on COPD, T2DM, and CVD. It also includes
general health information and information about preventive health services concerning
smoking, diet, exercise, and alcohol consumption. This information is provided by the
municipality, the Region of Southern Denmark, or the national health services, and targets
the individual (e.g. via links to apps and webpages) based on his/her specific health-risk
behavior.
The targeted intervention The intervention at the GP The intervention at the general practice
level consists of a focused clinical examination and a subsequent health dialogue and is
offered to patients who are at increased risk of developing an LRD (Group 2). Group 2
patients accept the offer of the intervention by scheduling an appointment at the GP (either
by phone or the GP's webpage). Group 2 patients also have the opportunity to register for a
telephone call from their GP on the digital support system. Whether the patient participates
in the intervention or not is thus determined by their motivation and capabilities as well as
the extent to which the content of the personal health profile motivates the patient to take
action. The intervention is applied within the framework of the 5As model. The focused
clinical examination includes measurements of blood glucose (HbA1c) and cholesterol levels,
as well as height, weight, blood pressure, and lung function measurements, and an
electrocardiogram (ECG), depending on the patient's health profile. Results from the
examinations are registered in the digital support system where both the patient and the GP
can access them at any time. Based on results from the health examination the GP may decide
to offer the patient a health dialogue in general practice or the intervention in the in the
municipality (described below). Patients offered a health dialogue in general practice are
given the opportunity to prepare for the subsequent health dialogue by answering a
questionnaire inspired by three systematic reviews on the determinants of behavior change.
These include questions about motivation, resources, former experiences with behavior change,
social network, mental health (WHO-5 for stress; Major Depression Inventory (MDI) for
depression, and an open field section to qualitatively report on perceived facilitators and
barriers to behavior change (a so-called balance-sheet). The questionnaire results are shared
with the GP on the digital support system. Based on the health dialogue, the GP and the
patient develop a prevention plan that includes a goal, a time frame, and identification of
the appropriate means to fulfill the plan (e.g. reference to a smoking cessation course, or
follow-up at the GP). The prevention plan is uploaded to the digital support system by the
GP, and henceforth is accessible to both the GP and the patient.
The intervention at the municipal level The intervention at the municipal level is offered to
patients exhibiting health-risk behavior (Group 3), and Group 2 patients referred to the
municipality by the GP. The intervention consists of a short telephone consultation with a
health professional - for example a nurse, a dietician, or a physiotherapist. A subsequent
face-to-face health dialogue is offered to patients who may benefit from more extensive
support. Patients request the telephone consultation on the digital support system by filling
in a short form and sending it by e-mail to the municipality. A municipal health professional
will then call the patient within the following week. Similar to the GP intervention, the
intervention at the municipal level is thus also determined by patient motivation and
capabilities as well as the extent to which the content of the personal health profile
motivates the patient to take action. Immediately after the intervention, a participation
form is sent to the municipality. Patients can prepare for the upcoming call from a municipal
health professional in the same way as Group 2 patients prepare for the health dialogue -
that is, by answering a short questionnaire. Ultimately, a prevention plan, including
concrete details on its execution, is developed based on the telephone consultation and the
face-to-face health dialogue. The prevention plan is registered by the municipal health
professional and presented on the digital support system to both the municipality and the
patient.
The entire intervention will be offered to the participants during a four-month period from
April to July 2019.
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