Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04304989 |
| Other study ID # |
P0031004 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 21, 2020 |
| Est. completion date |
October 20, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
The Hong Kong Polytechnic University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Homebound older adults are among the highest users in health care systems. The high use of
health care services is related to their physical limitations compounded by complex health
and social care needs. Homebound older adults can be difficult to reach because they seldom
participate and engage in community services due to their functional limitations, which
leaves their health needs largely unrecognized at an earlier stage. This study tries to bring
this group of older adults to the providers' attention and design a health-social oriented
self-care mHealth program and subject it to empirical testing.
Description:
Methods/Design The SPIRIT statement was used as a guideline for this protocol paper. Study
design and setting This is a single-blinded, two-armed randomized controlled trial. The
research assistant who collects the data is blinded, but the subjects and the health care
providers who are involved in the intervention are not. This study is supported by five
community centers. The centers are widely scattered across Hong Kong, which helps to maximize
the generalizability effect of this program.
Participants and recruitment strategy, and randomization The leaders of the community centers
will help draw up lists of potential subjects. Simple random sampling with a fixed sample
size will be employed to recruit subjects. The inclusion criteria of this study are (1) being
aged 60 or over, (2) going outdoors less than once a week in the last six months, (3) living
within the service area of a participating community center, and (4) ability to use a
smartphone. The exclusion criteria are (1) being diagnosed with dementia, (2) inability to
hear, see or communicate, (3) being bed-bound, (4) having an active psychiatric illness with
recent hospital admission within the last six months, (5) living within an area with no
internet coverage, and (6) being already engaged in other mHealth programs.
Potential subjects will be approached and invited to participate in the study. A consent form
will be signed once the subject agrees to participate. The random assignment schedule,
generated using the computer software Research Randomizer, will be compiled by a research
team member who is not involved in subject recruitment. The group assignments will be put in
a sealed envelope and revealed sequentially at the time of randomization. The research
assistant, after successfully recruiting a subject, will call the research team member for
the random assignment. The research team member who has no knowledge of the identity of the
subject will make the assignment based on computer numbers ('1' = video-based mHealth
program; '2' = control group).
Interventions A three-month program will be designed in this study. There will be two groups
involved in this study, described as follows.
Intervention group This group of participants will receive a video-based mHealth program that
includes two main elements: 1) nurse case management supported by a social service team, and
2) individual-specific video messages covering self-care topics delivered via smartphone.
Upon enrolment, each client in the intervention group will be assigned to a nurse case
manager. The nurse case manager will conduct a structured assessment via telephone call using
the Omaha System. The Omaha System is a comprehensive assessment-intervention-evaluation tool
that identifies 42 problems under the domains of environmental, psychological, physiological,
and health-related behaviors. The Omaha System has been found to be applicable for older
adults in the community and proven valid for use in Hong Kong. Following assessment, the
nurse case manager will guide and empower clients to set their own goals and co-decide their
own plans to manage their health problems.
Apart from monitoring clients' progress in accordance with their contract goals in a weekly
telephone call, the nurse case manager will also send weekly, individual-specific videos with
tips and reminders via smartphone. These videos cover topics of importance to clients
according to the results of the Omaha System. The content of videos includes but is not
limited to chronic disease self-management, healthy behaviors, simple self-care practices,
and medication knowledge. The selected videos are limited to 10 minutes to accommodate the
short attention span of older adults. All videos provided to the intervention group originate
from reliable sources such as the Hospital Authority, the Department of Health, or credible
health or charity organizations. The nurse case manager will first send a testing video to
the client in the first home visit to ensure that the client can receive the video on his/her
mobile. The client can either download the videos or view them online. The videos will run
continuously unless the client presses the "pause" button. Videos can be replayed once by
clicking the "play" button again.
A protocol for a referral system will be established with the full support of the
health-social team in accordance with the conditions and needs of the client. The nurse can
initiate a client referral according to the set guidelines. Health referrals include primary
care consultation and hospital service if indicated. Social referrals include home meal
service, psychological counselling and the like. In this team, the nurse case manager is
responsible for providing health-related services such as health education and drug
compliance monitoring, while social workers can provide services including arranging
home-delivered meals, providing psychosocial support, and mobilizing community resources
available in the district. A monthly case conference will be held in the community center
between the nurse case manager and the social worker. Issues such as the progress and any
concerns of the clients, suggestions for interventions, and requirements for modification or
adjustment of goals will be discussed during the meeting. The shared responsibilities are
based on standardized protocols and agreed referral forms and records.
Control group Both the intervention and control groups will receive their respective
community services as usual. The most common services provided by community centers include
meal and laundry services, transportation, health checks and education, and social
activities, but most of them are episodic in nature. Social calls will be provided to the
control group clients by a research team member who will not be involved in data collection,
to minimize possible social effects. Social questions such as "Where will you go tomorrow?"
and "What is your hobby?" will be set in the protocol. The research team member will follow
the protocol strictly and will not provide health advice. The older adult clients will be
encouraged to seek medical help whenever they express concern about their health.
Data collection Data will be collected at two time points-pre-intervention (T1) and
post-intervention (T2). The baseline and post-intervention data will be collected by the
research assistant, who will be blinded to the grouping. A previous study has found that
collecting data via telephone call can yield the highest response from homebound older
adults, since they seldom go out. The research assistant will be trained and tested on the
inter-rater and intra-rater reliability. Five percent of the data will be randomly selected
for independent review to ensure data quality.
Quality assurance mechanism This study will adopt a number of measures to ensure that the
intervention delivery is valid and reliable. The nurse case manager employed in this study
will have extensive experience in community elderly care, with competent level in using a
smartphone, good communication skills, and the ability to work with a team. A training
session will be given to providers in the areas of case management, the referral system, the
Omaha system, telephone counselling skills and guidelines for telephone follow-up. During the
training session and prior to actual implementation of the study, providers will be required
to provide interventions to a simulated client in front of the research team to ensure that
they understand and comply with the set protocols. The health-social team and the research
team will meet regularly to review and discuss the progress of cases.
Ethical considerations The present study was granted ethical approval from the Human Subjects
Ethics Sub-Committee (HSESC) of the University prior to the commencement of the study. This
study will not cause any pain or discomfort to participants. Information about and an
explanation of the ethical observations of the study will be provided to all eligible
participants, and they will be asked to sign an informed consent. Participants will be
reassured that they can withdraw from the study at any time without any adverse consequences.
They will remain anonymous and all data will be identified by a case number only. All data
collected from questionnaires will be stored in a password-secured cabinet.
Sample size The sample size calculation is based on power analysis. Assuming a two-tailed
alpha of 0.05, a probability of 0.2 for beta error (80% power), and an effect size of 0.45
with reference to previous video-based mHealth programs with the same primary outcome measure
(self-efficacy), 84 participants per group are required. With reference to the 10% to 15%
attrition rate reported in previous programs, we assume a 15% drop-out rate in this study,
thus the total sample size needed is 97 participants per group, i.e. a total of 194
participants. However, since this is a pilot study, at least 9% of the sample size of the
main planned trial should be used. To ensure that the power is enough to estimate the group
difference, this will be set at 35% of the sample size of the main planned trial. The total
number of clients required is therefore 68. The flow of this study will follow the Modified
CONSORT Statement extension for individual randomized controlled trials of
non-pharmacological treatments.
Data processing and analysis The research assistant and the research team member will
independently enter the data into the SPSS software (version 25.0, IBM). The inconsistencies
between these two files will be resolved by retrieving the raw data from the questionnaires.
Descriptive statistics will be used to detect potential outliers.
The participants' baseline characteristics will be compared using the chi-squared test or
Fisher's exact test (in case the expected frequencies in any of the cells are lower than 5)
for categorical variables and the two samples independent t-test for continuous variables.
The p-value is set at less than 0.05 as a significant result for the two-tailed test.
The between-group (group), within-group (time), and the interaction effects (group x time) of
outcome variables will be analyzed using the Generalized Estimating Equation (GEE). Linear
link function will be used for all outcome measures except health service utilization while
Poisson link function will be employed for health service utilization outcomes. Unstructured
working correlation matrix will be adopted to indicate the same spacing between measurements
for each subject. Adjusted GEE models will be employed to evaluate each outcome measures. All
analyses will be conducted according to the intention-to-treat (ITT) method.
