Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06077565 |
| Other study ID # |
GHPED |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2024 |
| Est. completion date |
May 31, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Chinese University of Hong Kong |
| Contact |
Ho Cheung William Li, PhD |
| Phone |
39430889 |
| Email |
williamli[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Aim To examine the effectiveness of a general-health-promotion-approach to help ED attendees
change their health-risk behaviours and lead healthier lives.
Hypotheses to be tested The investigators hypothesise that compared with those in the control
group, the participants in the intervention group will experience significantly greater
success in changing their health-risk behaviours and will have a better health-related
quality of life at 12 months follow-up.
Description:
Study design A RCT with a two-group pre-test and repeated post-test between- subjects design
will be conducted.
Setting:
The setting is the ED of the United Christen Hospital (UCH), one of the major acute care
hospitals in Kowloon East cluster in Hong Kong.
Conceptual and theoretical framework:
The proposed intervention is guided by the foot-in-the-door technique, and self-determination
theory.
Foot-in-the-door technique The foot-in-the-door technique, which was introduced by Freeman
and Fraser, emphasises the notion that individuals who initially comply with a small, easy
request are more likely to later comply with a larger request. Compliance with the first
request or target increases the individual's confidence and alters their self-perceived
capability and willingness regarding further requests or targets. This technique can
facilitate the recruitment process and enhance compliance.
Self-determination theory According to self-determination theory, behavioural regulation is
more autonomous when it is internalised, as opposed to being regulated by external factors
(e.g., orders from family members, friends, or healthcare professionals). Compared with
external regulation, autonomous regulation is associated with increased self-efficacy,
greater behavioural persistence, longer-term behavioural changes and more positive health
behaviour. Autonomy is another influential determinant of behaviour that is emphasised by
freedom of choice. There is some evidence that supports a positive association between
autonomy and competence, with people who have greater autonomy demonstrating greater
competence in achieving behavioural change compared with those with less autonomy. Evidence
suggests that patients who have the opportunity to decide on their own treatment may be more
eager to comply with instructions. The participants in this proposed study will be allowed to
select their priorities in engaging in desirable health-related lifestyle practices after
discussion with the research assistant. It is anticipated that the participants will show a
greater willingness to adhere to their desired health-related lifestyle practice as a result
of this increase in autonomy. Moreover, there is some evidence for a positive association
between autonomy and self-efficacy; that is, people who have greater autonomy demonstrate
greater self-efficacy for achieving behavioural change. As a result, increased autonomy will
facilitate a gradual change in risky behaviours.
Our intervention, therefore, aims to first change the participants' attitudes and their
subjective norms through risk communication. By using the foot-in-the-door technique and
self-determination theory, it will then enhance the participants' self-efficacy in changing
their health-risk behaviours.
Intervention
At the ED All potential participants will be approached by emergency nurses before being
discharged home from the ED. The emergency nurse will provide potential participants with a
leaflet detailing the nature and purpose of the study. Potential participants can express
their willingness to participate in the study by signing an informed consent form. The
emergency nurse will then refer the participants to the research assistant. Participants will
be informed that they will receive a telephone call from a research assistant within 3 days
to evaluate their potential health-risk behaviours and provide them with appropriate health
advice to lead healthier lives. The participants will also be given a Practical Resource Hub
for Healthy Life leaflet containing information on various applications, including (i) 'Move
Your Body', (ii) 'Eat Healthy', (iii) 'Live Alcohol Free', and (iv) 'Stay Away from Tobacco',
which were developed by the Hong Kong Department of Health.
1. Intervention group Brief intervention via telephone (within 3 days after visiting the
ED) The participants will receive a brief intervention using the Ask, Warn, Advise,
Refer and Do-it-again (AWARD) model, which was originally developed for primary-care
tobacco-cessation interventions. The brief intervention includes the following steps:
(1) ask about and assess health-risk behaviours; (2) warn about the high morbidity and
mortality risks associated with health-risk behaviours; (3) advise to adopt healthy
lifestyle practices to benefit the health of the participant; (4) refer to hotline
services on request, such as smoking cessation and alcohol treatment services; and (5)
do it again. For the warning message, the research assistant will provide the following
standardised message: 'The WHO has identified four major behavioural risk factors,
namely, tobacco use, harmful alcohol use, an unhealthy diet and physical inactivity,
that contribute substantially to NCDs, which result in high rates of morbidity and
mortality.' For the advice step, the research assistant will ask about the priority the
participants place on engagement in desirable health-related lifestyle practices
identified in the completed behavioural risk factor survey. The participants will also
be asked to choose the goal that they consider easiest to achieve, such as quitting or
reducing smoking, consuming more vegetables or less fatty foods or sugary drinks,
performing more exercise or reducing alcohol consumption. The participants will be
encouraged to quit health-risk behaviours (or adopt a healthy lifestyle) sequentially,
but they will also be able to choose to quit them simultaneously if they are confident
in doing so. Each participant will then receive a brief (approximately 5 minutes),
individual intervention with health advice about the selected health-related lifestyle
practice. The whole intervention will last approximately 10 minutes, but slightly longer
if necessary. Such a brief intervention will be more feasible for routine use in
clinical practice by healthcare professionals after minimal training. Previous clinical
trials of smoking cessation have provided strong evidence regarding the effectiveness of
brief interventions using the AWARD model.
At the end of the telephone call, the participants will be informed that throughout the
study period, the research assistant will assist in achieving the participant's
health-related goals by sending WhatsApp/WeChat messages or via telephone calls.
Follow-up booster intervention (up to 6 months) For the first 6 months of the study
period, the research assistant will deliver WhatsApp/WeChat messages about once per
week. If a participant does not own a smartphone or is unable to receive WhatsApp/WeChat
messages (uncommon in Hong Kong), the research assistant will make a telephone call,
instead of sending a message, as a reminder for the participants to adhere to their
desirable health-related lifestyle practice. Instant messaging via mobile applications
has found to be effective in enhancing treatment compliance.
Follow-up assessment of behavioural changes at 3, 6, and 12 months The participants will
be assessed to determine their success in changing their targeted health-related
lifestyle practice via a phone call at 3, 6, and 12 months.
2. Control group The control group participants will receive a brief telephone intervention
based on the AWARD model and delivered by the trained research assistant, similar to
that delivered to the intervention group. However, the research assistant will simply
advise the participants to change their health-risk behaviours and/or adopt a healthy
lifestyle practice. The participants will also receive follow-up for outcome assessments
with the same schedule as those in the intervention group.
Randomisation method To avoid the potential risk of treatment contamination within the ED,
randomisation will not be performed there. Instead, the research assistant will input the
baseline data collected at the ED directly into the web-based trial entry form linked to a
computerised database, and randomisation will then be performed at the Principal
Investigator's (PI's) institution by an independent statistician who will have no other
involvement in the study. Stratified block randomisation with 1:1 allocation will be
conducted using varying block sizes of 2-4 to achieve an appropriate balance of participant
numbers between the two groups and to optimise allocation concealment. In addition, the
randomization will be stratified by health-risk behaviours (tobacco use, harmful use of
alcohol, unhealthy diet, and physical inactivity) to yield a good balance of participant
numbers with different lifestyle risk behaviours in the two groups. The subjects will not be
able to change group after randomisation.
Sample size G*Power is used to estimate the sample size based on the results of our pilot
study. The pilot study showed an approximately 10% between-group difference in reports of
successfully abstinence from at least one health-risk behaviour between groups at 12 months
(the primary outcome of this proposal). To detect a significant difference in the proportion
of participants quitting health-risk behaviours or adopting healthy lifestyle practices
between the intervention and control groups, with a power of 80% and a significance level of
5% (2-tailed), at least 199 participants will be needed per group. To account for a potential
attrition rate of 30% at the 12-month follow-up assessment, totally 568 participants will be
recruited.
According to the Hospital Authority Annual Report,9 there were 140,273 visits in ED of UCH
between 2021 and 2022. Furthermore, according to our previous pilot study conducted in ED of
UCH, the investigators are confident that they will be able to recruit the required number of
participants (N =568) within 15 months.
Data Analysis The baseline characteristics of the two groups will first be compared using the
chi-square test for categorical variables and analysis of variance for continuous variables.
An intention-to-treat analysis will be used by imputing all non-responses at follow-up by
baseline values (i.e. assuming failure or no change after the intervention), to yield more
conservative effect size estimates.
SPSS for Windows (SPSS version 26.0; IBM Corp., Armonk, NY, USA) will be used for the
quantitative data analysis. Descriptive statistics will be used to calculate the mean,
standard deviation, and frequency of the demographic and health-risk behaviour data. The
primary analysis including the main effect, i.e., behavioural changes at 12 months in the
intervention group versus those in the control group, will be performed using a chi-square
test or Fisher's exact test. The secondary analyses will (1) assess the main effect adjusted
for baseline differences, (2) assess the secondary outcome (health-related quality of life)
at 6 and 12 months, and (3) construct a generalised estimating equation model (GEE). The GEE
model will be used to calculate the adjusted odds ratios for the self-reported number of
successful health-risk behaviours quit and the number of healthy lifestyles practices engaged
in, after adjusting for the baseline demographic and clinical characteristics that show
significant differences, and the within-subjects effect of the repeated-measure outcomes (6
and 12 months).
The investigators will conduct a cost-effectiveness analysis CEA using standard methods. The
CEA will be populated using empirical 12-month RCT data. An ingredients approach will be used
to estimate the cost of the intervention programme, including that of the intervention
material (e.g., leaflets and videos), the administration cost, and the time taken to deliver
the intervention. The health effectiveness outcomes will include the number of participants
who have quit health-risk behaviours at 6 and 12 months and their QALYs.
