Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04668560 |
| Other study ID # |
59001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2020 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
December 2020 |
| Source |
Norwegian Institute of Public Health |
| Contact |
Maja ME Eilertsen, MD |
| Phone |
+47 95895434 |
| Email |
maja.eilertsen[@]fhi.no |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Norway and other Western industrialized countries are facing major challenges in terms of
preventable health problems, high work absence, largescale demographic changes and rising
social inequalities in health. By applying an interdisciplinary research approach -
integrating perspectives from psychology, sociology, medicine and economics, using multiple
samples and complementary analytical strategies, this project addresses the need for
effective means to meet these important challenges. The project will scientifically evaluate
The 5 Ways to Wellbeing course (5Ways), a novel measure aiming to promote wellbeing and
integration, health and work adherence. Subjective wellbeing is systematically and
prospectively related to important individual and societal outcomes, including social
connectedness and integration, innovation, productivity, work performance, healthy
behaviours, health and longevity. Promotion of wellbeing may therefore contribute to address
the urgent societal ailments of today. Intervention effects and cost effectiveness of the
5Ways will be examined in-depth in four real-life settings, using quantitative and
qualitative methods. Specifically, we will investigate course impact on i) sickness absence
for employees in work places with high sickness absence rates, ii) wellbeing, health and
social participation among immigrants attending the municipalities? Introduction Programmes,
and iii) wellbeing, health and work adherence among users of The Norwegian Labour and Welfare
Administration (NAV) and iv) clients in Healthy Life Centres. If effective, the course may be
implemented nationwide and contribute to increase wellbeing and work participation and reduce
immigrants? exclusion. Findings from the study may thus contribute to enable municipalities
and workplaces to make better priorities for promoting work presence, reducing suffering and
improving mastery and quality of life among their employees and inhabitants
Description:
Sample:
The sample consists of individuals attending the 5Ways course offered in Healthy Life Centres
HLCs (N=600) and in NAV centres (N=120), and two groups of control subjects. The control
groups include i) 1200 individuals participating in the FLS study and ii) 120 individuals in
NAV receiving follow up as usual. The target group for the 5Ways course consists of
individuals with, or at high risk of disease, who need support in health behaviour change and
in coping with health problems and chronic disease. HLCs are interdisciplinary primary health
care services that offer effective measures for people who need support in health behaviour
change and in coping with health problems and chronic disease. All 5Ways course participants
in HLCs will be invited to enrol in the study. In total, the investigators estimate that at
least 30 HLCs will participate in the study and offer the 5Ways course in 2021. Given a
minimum of two courses per year per HLC, the investigators assume that altogether 600
participants from HLCs will be included in the study in 2021. The second group of course
participants will include individuals on sick leave, work assessment allowance and disability
pension who receive the 5Ways course through NAV. NAV currently administers a third of the
national budget through schemes such as unemployment benefit, work assessment allowance,
pensions, etc. The NAV participants will be randomised into an intervention group or a
control group. Exclusion criteria for participation in the course include impaired cognitive
functioning and severe mental illness.
The Course Intervention. The participants will attend the course for 2.5 hours across six
weeks, one session dedicated to each of the five actions, and the last session for
summarising, sharing and evaluating. The course is ready to be implemented. The course
leaders are HLC coaches and NAV employees, with a minimum of three years of relevant
education who are certified to run the 5Ways course. Course leader training consists of a
two-day intensive, highly standardized training program. All course leaders receive a
comprehensive manual to be followed through the course. The participants receive standardised
course material.
The Pilot Study. During spring 2018, a pilot study was conducted on the 5Ways course in 12
HLCs in the South-Eastern part of Norway. A total of 89 participants completed the evaluation
questionnaire. The evaluation report concluded that the participants were highly satisfied
(score: 8.7/10), intended to continue to practice what they had learnt and experienced
improved wellbeing.
Research hypotheses.
The investigators hypothesize that participating in the 5Ways course will improve wellbeing,
physical and mental health, mastery and social participation, and thus ultimately reduce the
burden of disease, reduce utilisation of health care services, and increase work
participation. The investigators will examine effects on all outcome measures in different
vulnerable groups short term, after completion of the course, and long term, after 15 months,
on participants in HLCs and users on welfare benefits in the NAV system. The investigators
have three main hypotheses:
1. The 5Ways course improves wellbeing, physical and mental health and mastery, short term
and long term.
2. The 5Ways course reduces loneliness, strengthens social integration, and increases
social support, short term and long term.
3. The 5Ways course increases return to work and long-term work participation in
individuals on sick leave or welfare benefits.
Design. The design is a prospective controlled comparative study, using two different groups,
with and without randomisation. Group 1: Participants referred to HLCs, and group 2:
Individuals receiving welfare benefits from The Norwegian Labour and Welfare Administration
(NAV). The long-term results from group 1 will be compared to a group of HLC users not
offered the course (i.e., participating in the ongoing FLS-study).
A randomised controlled trial (RCT) was originally planned for both HLCs and NAV. However,
both end users and HLC coaches urged the investigators to avoid randomisation in HLCs. HLC
participants often need to build up the courage to seek help over time. Randomisation to
no/delayed course (e.g., waiting list control) was therefore considered unethical. In NAV,
the users have not requested health care services. Hence, not being offered the course is
"treatment as usual". By conducting a study in NAV, the project meets the gold standard of
using a RCT.
Group 1. Participants referred to HLCs, receiving regular HLC services, will be offered the
course and invited to participate in the study. The HLC coaches will be responsible for the
recruitment of course participants. Control for group 1. A large-scale study on effects of
participation in HLCs, the FLS-study (Frisklivsstudien, N=1200) is about to be completed. The
FLS participants are similar to our group 1 in terms of characteristics. The FLS study also
include some of the outcome measures to be used in our planned study. The FLS data thus give
the investigators the opportunity to compare the 5Ways course with effects of basic HLC
interventions (i.e., 12 weeks follow-up of health behaviour change by a HLC coach). Group 2.
People on welfare benefits, such as long-term sick leave and disability pensions, in the
NAV-system will be recruited by NAV employees and randomised into two groups, an intervention
group and a control group. The intervention group will participate in the course, and the
control group will be followed up as usual in NAV (i.e., not offered the course). In groups 1
and 2 the participants will receive the questionnaire at the start of the course, at the end
of the course, at 6 months and at 15 months. Four measurement waves enable the investigators
to model long-term changes in the outcome variables after the intervention using multilevel
methods, as this requires at least three measurements in the follow up phase. Although one
would expect some dropout, all the available data will be useful in this approach, as it does
not require listwise deletion of individuals with missing data. There will be approximately
70 courses altogether, 60 in HLCs and 10 in NAV. This will allow the investigators to
investigate the extent to which course effects and the subsequent developmental trajectories
in participants differ between groups. The investigators can also account for this
variability by including level two predictors, such as the course leaders' fidelity to the
manual. Follow-up data collected after 15 months will be compared to the 15 months' follow-up
data in the FLS study. This design enables the investigators to examine potential effects in
two ways: 1. Examine the added effect of the 5Ways course to ordinary HLC services at 15
months. 2. Examine the effect of the course in a group of individuals on welfare benefits
compared to a control group in NAV.
Instruments. Subjective wellbeing is the primary outcome in this study. Secondary outcome
measures are physical and mental health, mastery, social integration, physical activity, use
of health care services and work adherence. Measurement tools in the recent report on
recommendations for a better quality of life measurement system, will be used. These include
OECD's recommended minimum-tool for assessing quality of life, Diener's flourishing scale,
Satisfaction With Life Scale (SWLS), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS),
Pearlin and Schoolers Mastery Scale, Patient Health Questionnaire (PHQ-2), Oslo Social
Support Scale (OSS-3) and Hopkins Symptom Checklist (HSCL). In addition, the investigators
will use The Short Form Survey-12 (SF-12) and standardised questions on physical activity
from the North-Trøndelag Health Survey (HUNT). The latter questions are used in the
FLS-study. Background data such as age, gender, education, work attachment, economy and
relationship status will also be collected. Three user representatives have tested the
questionnaire, and provided useful feedback resulting in minor revisions. Procedure. The
study participants will fill in the questionnaire on the first and last course sessions. For
the 6 and 15 months' follow-up, the participants will receive a SMS with a link to a common
web page where the questionnaires may be completed. Digital data collection makes it easier
to complete the questionnaires and ease the computing processes. The project will use
external data management services that will program and test the digitalisation of the
questionnaire. The data will be transferred into data files ready for use by the PhD
candidate. Price estimates have been provided by suppliers of such services, and services
will be acquired in line with public procurement policies. The PhD candidate will be in
regular contact with the data management company and with HLC and NAV course leaders via
email and telephone, ensuring timing of the SMSes to the measurement times. The PhD candidate
will introduce the course leaders to the study during their two-day course leader training in
2020.
Data analysis. The effect analysis of the primary outcome will involve a comparison of
self-reported wellbeing at course start and course end, using a two-way repeated (mixed)
measures ANOVA. Additionally, longitudinal analyses will be conducted by fitting linear mixed
(multilevel) models to data from all five time points. Mixed modelling is flexible and can
handle non-balanced data with missing entries and repeated observations. The models allow the
investigators to examine the effectiveness of the intervention and test hypotheses about
group and individual trajectories in wellbeing, while controlling for both time variant and
invariant covariates. Follow-up analyses will be conducted using various time-to-event
approaches. Analyses will be performed in SPSS 25.0 (SPSS I, 2017) and R 3.5.3 (R Core Team
2019). Sample size and power. Simulations were performed in R 3.5.3 to assess power to detect
an increase in wellbeing of 4.3 units from a baseline score of 12.5, the magnitude found in
the pilot study, for each of the two subsamples (n=600 and n= 120) in both intervention and
control groups, (sd=5, rho=0.5). Power to detect an interaction effect in mixed ANOVA (two
tailed test, α=0.05) was found to be 1.0 (HLCs) and 1.0 (NAV), which is adequate, also
allowing for dropout of 17 %. Although dropout is expected to increase for the later
measurements, the multilevel analysis ensures utilisation of all available data. Power is
higher in the linear mixed models, with data from additional three time points included for
each participant.
The dissemination plan.
The dissemination plan will be the key tool to make the project findings available and
relevant to the main stakeholders (users and staff), private, ideal and governmental users,
the scientific community, and the media. The NCMH, core scientists and user groups will be
actively involved in dissemination of all findings. Results from the project will be
published in high quality open access international peer reviewed journals. Tentative titles
of papers:
1. The 5 Ways to Wellbeing course: The effects on wellbeing, physical and mental health and
mastery. A randomized controlled trial.
2. Reducing loneliness and improving social integration and social support: The long-term
impact of the 5 Ways to Wellbeing course.
3. Effects of the 5 Ways to Wellbeing course on work participation in adults on sick leave
and welfare benefits in The Norwegian Labour and Welfare Administration (NAV).
Additionally, results from the project will be published in condensed form accessible to both
professionals and non-professionals by several means of dissemination. These include national
conferences (e.g., HLC network conferences), Norwegian Institute of Public Health (NIPH)
reports and newsletters, press releases for each scientific paper, and activity in social
media.
