Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02971241 |
| Other study ID # |
UP-15-00270 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2015 |
| Est. completion date |
April 2019 |
Study information
| Verified date |
May 2019 |
| Source |
University of Southern California |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary purpose of the study is to understand the potential of mobile computing
technology to improve chronic disease self-management, quality of life, and health outcomes
of older adults to prevent or alleviate future disabilities. Thus, the study will design,
develop, and test an intervention to motivate and train seniors to use the technology, and
conduct a trial to evaluate its effect. This innovative intervention will deploy young
generation (age 18 to 30) volunteers to provide mobile technology training, access, and
support to older adults (aged 55 and above) with type 2 diabetes in Taiwan. Hence, a
secondary purpose of the study is to understand the effects of the volunteering experience on
the values, characters, and health awareness in the young generation. This program, called
the Intergenerational Mobile Technology Opportunities Program (IMTOP), will help older adults
with type 2 diabetes acquire skills to use the Internet, World Wide Web (WWW), applications
(or "apps"), and basic computing via mobile tablet devices. These skills will give
participants access to resources and tools to improve health and mental health, reduce social
isolation, and increase social engagement, as well as meet their individual life goals. The
course will use young volunteers to deliver the tablet training. The training course will be
offered as small-group sessions over an 8-week period (for up to 16 hours of training) at a
hospital site, plus young volunteers' technical support and problem solving for up to 4 weeks
after the training sessions are completed. Using college students to serve as volunteer
trainers for teaching mobile technology, the research also aims to understand not only how
the intergenerational interactions help the older adults learn the technology and improve
health, but also how the tutoring experiences make impact on the young adults' skills and
perspectives that will help them in their future careers and in the development of their
characters. This research study will recruit three hundred fifty (350) patients from the
collaborating hospitals, including two hundred fifty (250) patients from Taipei Tzu Chi
Hospital and one hundred (100) patients from Hualien Tzu Chi Hospital. An estimate of 140
students in colleges and universities in Taiwan (100 volunteers in Taipei hospital and 40
volunteers in Hualien hospital) between the age of 18 and 30 will be recruited to serve as
volunteer instructors to teach older adults to use tablets and to provide technical support
services. Moreover, another group of 140 young adults, also age 18 to 30, will be recruited
from universities to serve as the comparison group to the volunteers in intervention group.
The course objectives are to guide older patients with Type 2 diabetes to use technology to
obtain diabetes-related medical information, learn to record and control their physiological
data via technology, promote intergenerational communication, enhance the convenience in
life, and improve social life and mental health through technology tools such as the
Internet, social media, online health education resources, instructional videos and so on. It
is hoped to further slow down degradation, promote health and prolong life.
Description:
The research design is a randomized waitlist control trial. Patients will be randomly
assigned to the immediate intervention group or 4-month waitlist control group. The former
will immediately join the tablet computer courses, while the later will wait for four (4)
months before starting their courses. The follow-up period for patients will be one (1) year
after the start of courses. Patient assessments will include baseline and follow-up
assessments of health behaviors, functional status, health conditions, and social
interactions and engagements, plus technology use and acceptance. Baseline assessment will be
conducted at recruitment for all patients, and for waitlist control group again at the
beginning of the course. Follow-up assessments will be conducted at four (4) months, eight
(8) months, and twelve (12) months after the start date of the courses. Young volunteers will
also be assessed to understand their experiences in the volunteering services and any impact
from this experience. The assessments will be conducted at the baseline, during the courses,
and two (2) months and four (4) months after the beginning of the courses. In addition, a
group of 140 young adults will be recruited from universities to serve as the comparison
group and will be asked to complete the assessment survey at baseline, two (2) months, and
four (4) months later.
For older adults:
Patients who meet inclusion criteria will be referred by doctors in the metabolism and
endocrinology department of the two hospitals to recruiters and will be randomly assigned to
immediate intervention group and waitlist control group. The aim of the comparison is to
assess the potential effects of mobile technology program with intergenerational interaction
on patients' technology use, self-efficacy, self-management behavior, and social engagement,
and whether it results in less social isolation and health care utilization, improved health
and mental health status, and greater quality of life.
Recruitment procedure:
1. Tzu Chi diabetes health educators will recruit patients with type 2 diabetes and screen
them for eligibility. The health educators will complete a patient contact card for each
patient that they screen for eligibility. If eligible, the health educators will explain
the study to the patients and ask for their interest to participate. Interested patients
will be referred to an IMTOP study recruiter. The recruiter will collect all patient
contact cards and completed screeners from the health educators.
2. The study recruiters on site in the hospital will obtain the informed consent from the
eligible and interested patients. When the patients sign the study consent, the
recruiter will write on the patient contact card the patient ID next to Study
Participation Status - Enrolled, and complete the patient contact card.
3. The recruiter will then conduct the baseline interview. Baseline interview can be done
face to face or via telephone if patient prefers.
4. Patient's study group (immediate intervention or wait list control group) will be
randomly assigned at the study's Qualtrics database after baseline interview is
complete.
5. All recruitment paper, if any, will be sent to the project manager to file on a locked
cabinet.
6. The patients who are randomized to the immediate intervention group will be assigned to
the training course as soon as a course is available. The patients randomized to the
waitlist control group will need to wait for six months to serve as no intervention
control, and then assigned to the training course.
Description of intervention:
The intervention is a 12-week program which consists of 8-week training sessions followed by
4-week consultation service for technical support. Both will be provided by the young
volunteers. The themes of the 8-week training session are designed based on the objectives of
IMTOP: 1) teach skills of tablet use, 2) introduce online community communication to decrease
social isolation and obtain social support from family and friends, young volunteers, health
care providers, and diabetes peers who have similar condition/interest/ or disease), 3) teach
diabetes self-management knowledge and skills based on the evidence-based Chronic Disease
Self-Management Program; and 4) teach mobile technology application to healthcare access and
daily needs (i.e., online appointment, online refill, appointment reminder, online health
information, online training videos, and virtual classes such as e-newspaper, e-books,
related sites, apps).
Moreover, the enrolled older adults will be invited to use a diabetes self-management
behavior tracking app developed by the research team. The app is designed to encourage
diabetes patients to regularly record their diet, physical activity, water consumption,
medication adherence, blood sugar readings, and blood pressure readings. The data will be
used for our research analysis to understand to what extent the older adults use the app and
whether regular recording has impact on the outcome measures.
The 4-week consultation service post the 8-week training course is intended as additional
support for the older adults who encounter technical issues when using the tablet on their
own. To receive the technical support, the older adults shall call the study hotline or post
their questions on the study website to explain the technical issues. The research staff will
find a study volunteer to address the technical issues.
During the training sessions in the classroom, the research team may audiotape, videotape, or
take photos to record classroom interactions between older adults and young volunteers. The
recordings will be no more than half of the 8 sessions and each time we may videotape up to
90-min per session. The purposes are for quality improvement of the IMTOP program, for
research analyses at the aggregate level, and for dissemination of the program. The
participants have the rights to decide whether to be taped or photographed. They may indicate
their decision on the consent form or by telling the recorder/photographer at the time of the
taping/photo shooting.
Accrual and baseline data collection:
University of Southern California (USC) research team will prepare enrollment packages
(including an information sheet, the screener, the patient contact card, the consent form,
HIPPA form and a 40-minute baseline survey). Health educators employed by two Tzu Chi
Hospitals will help enroll and consent eligible patients. Participating patients will be
asked to sign the HIPPA authorization form to release their medical records in hospitals.
Consenting patients will be invited to take baseline survey through an interview with a study
interviewer, either in-person or by phone based on patient's preference. When baseline survey
is completed, patients will be randomly assigned to intervention group and wait-list control
group.
Follow-up survey: For immediate intervention patients, 4-month, 8-month, and 12-month
follow-up surveys will be administered via telephone by part-time interviewers employed for
the study by the hospitals. For wait-list control group patients, 4-month, 8-month, 12-month,
and 16-month follow-up surveys will be administered via telephone by the part-time
interviewers. Study data will be obtained from patients' self-report on study assessments,
study tracking records such as the training course attendance, and patients' medical records
pertaining to diabetes care and healthcare utilizations in Taipei and Hualien Tzu Chi
Hospitals. Self-report data collected from patients include demographic characteristics,
physical health and mental health status, self-management behaviors, health care utilization,
health literacy, self-efficacy, social engagement, and quality of life. The study assessments
and study tracking records will be conducted exclusively for research purposes.
For young volunteers:
Accrual and baseline data collection:
IMTOP research staff and employees (such as diabetes health educators) of the Taipei and
Hualien Tzu Chi Hospitals will distribute young volunteer recruitment flyers to officer of
student affairs and faculty at various universities nearby the study sties. The IMTOP
research staff will also arrange meetings at university campuses to introduce the study and
call for volunteers. The study information and the call for volunteers will be disseminated
campus wide two months prior to each IMTOP training term starts.
Young adults who are interested in participating in the study as volunteer instructors for
the training course will sign up at the study website IMTOP.usc.edu. The sign-up section of
the website will explicitly show the language that enrollment in the study means a volunteer
is not only serving as an instructor but also as a research participant. To complete the sign
up will require acknowledgment of the dual roles. There will be a study hotline number shown
on the recruitment flyer for interested young adults to get more information about the study
and for sign-up. The research staff will contact those young adults who meet the study
inclusion criteria for an interview to clarify the job responsibilities and the expectations.
Those who agree to meet the expectations will be invited to attend the two-day training
workshop (described below).
On the day of the training workshop, the young adults will be asked to consent for their
study participation and to complete the study baseline. Then they will be accepted for the
study enrollment as young volunteers. The target recruitment is 140 volunteers.
USC research team will prepare the enrollment package (including the recruitment flyer, the
sign-up form, the consent form, and a 40-minute self-administered baseline survey). The
sign-up and the consent form will be available via the study website IMTOP.usc.edu. The
self-administered surveys will be available on qualtrics website via a web link in the study
website.
Orientation workshop:
USC research team will provide two orientation workshops for enrolled volunteers to learn
skills and knowledge for delivering the intervention service. The topics of orientation
workshops include young volunteers' role and responsibilities in the IMTOP research project,
knowledge of aging process, motivational interviewing skills, problem solving skills,
empathy, communication with older adults, and introduction of the 8-week training curriculum
and the 4-week technical support.
Volunteering services:
After the orientation workshop is successfully completed, young volunteers will be assigned
to be one of about 4 instructing volunteers to provide the tablet training for a group of
approximately 10 older adults with type 2 diabetes. The training course is 2 hours per
session and 1 session per week for 8 weeks long. In each session, there is a prepared course
material for the volunteers to deliver to the older adults, such as use of web browsers,
application of social media, and online supporting materials for the older adults to learn
mobile technology for their self-management to improve health and quality of life. After the
8-week training period, the young volunteers will provide 4-week technical support for the
diabetes outpatients via phone or mobile device.
During the tablet training sessions in the classroom, the research team may audiotape,
videotape, or take photos to record classroom interactions between older adults and young
volunteers. The recordings will be no more than half of the 8 sessions and each time we may
videotape up to 120-min per session. The purposes are for quality improvement of the IMTOP
program, for research analyses at the aggregate level, and for dissemination of the program.
The participants have the rights to decide whether to be taped or photographed. They may
indicate their decision on the consent form or by telling the recorder/photographer at the
time of the taping/photo shooting.
Baseline and follow-up survey:
The enrolled young volunteers will be asked to complete the self-administered online surveys
at baseline and at 2-month and 4-month follow up. That is, the baseline will be completed
prior to the intervention. The 2-month follow-up will be completed immediately after the
8-week training course. The 4-month follow-up will be completed one month after the 4-week
technical support period. The survey will collect data about demographic characteristics,
level of empathy, citizenship behavior, time management skills, altruism value, purpose of
life, and career development. In addition, the young volunteers will be asked to take turn in
recording the class log, including the class attendance, materials taught, Q&A, any
difficulty or questions in delivering the curriculum, and other relevant observations or
issues. Additionally, once a month for a total of three times, once in week 4 and once in
week 8 during the 8-week course, plus once in the end of the 4-week technical support, they
will be asked to write a short reflection of their volunteering experience. These study
assessments and study tracking records will be conducted exclusively for research purposes.
For young adult comparison group:
A group of 140 young adults similar to the young volunteers will be recruited from
universities through information meetings held by the research staff in collaboration with
officer of student affairs and faculty at various universities. They will not be randomized,
but instead they will be deliberately recruited to be the comparison group that matches with
the young volunteer group on the bases of age range, college attendance and major, and
location of the schools. These young adults will be informed to serve as the comparison group
for the study. Once consented, they will be directed to answer the same self-administered
online surveys at baseline and at 2-month and 4-month follow up.
Data Storage and Confidentiality:
1. All questionnaires completed electronically via the web-based survey company qualtrics,
license available through the USC Information Technology Services
(http://www.usc.edu/its/qualtrics/), will be kept in the secure website of qualtrics and
then downloaded into a centralized database located in the USC School of Social Work.
The following links show privacy, acceptable use, and security statements provided by
qualtrics:
http://www.qualtrics.com/privacy-statement/
http://www.qualtrics.com/acceptable-use-statement/
http://www.qualtrics.com/security-statement/
2. Data collected on the study website IMTOP.usc.edu will be stored in secure and password
protected website at Amazon Cloud Drive, and then downloaded into a centralized database
located in the USC School of Social Work.
3. A password protected secure computer file linking identifying information and the
subject study ID will be securely maintained under control of Dr. Wu and the study Data
Analyst in the School of Social Work.
4. All study data files will only contain subject IDs, not identifying information.
5. Analysis and publication of the data will employ procedures making it impossible to
identify individuals.
6. After completion of the study, identifiable data such as video tapes will be destroyed,
but the remaining data will be retained at the researchers discretion and may be used in
future research studies. ..
7. All study investigators and staff have already or will complete the USC IRB and required
HIPAA certification course.
Hardcopy study data will be kept in the secure location in the USC School of Social Work or
in a designated locked cabinet in the collaborating Tzu Chi hospitals for a period of 5 years
following study completion, after which it will be destroyed. Study tracking data will also
be kept on a secure, password protected, web-site maintained by the School of Social Work
within the Hamovitch Research Center.
RISK/BENEFIT ASSESSMENT
Potential Risks:
There are no anticipated risks to subjects' participation in this study. The tablet training
program takes place in Taipei or Hualien Tzu Chi Hospital. Subjects' participation in the
program may involve normal risks in transportation to attend the training sessions. Frequency
and intensity of training sessions might cause them certain level of anxiety and discomfort,
such as soreness in eye.
As the study subjects will also participate in the study surveys, some of the survey
questions may make them uncomfortable or concerned, but they can choose not to answer any
questions they do not wish to answer. Participating in research may involve a loss of
privacy, but all of the information the subjects provide will be kept confidential. The
possibility of a breach of privacy to occur is very low but will exist as long as we hold the
data.
All participants will be advised that they are free not to use the technology and not to
answer any questions that make them uncomfortable. However, in previous studies of depressed
patients, distress resulting from interviews and questionnaires has been minimal. Subjects
may experience inconvenience and time costs associated with using technology and completing
study interviews; however, all interventions and interviews are completely voluntary and will
be conducted at the participant' convenience.
The technology intervention does not expose patients to additional or unusual medications or
side effects.
Although all efforts will be made to protect patient confidentiality, those patients who
experience critical clinical events (e.g., hypoglycemia) during the study training sessions
or those who are likely victims of abuse may experience loss of confidentiality as study
staff will be required to report these events to the subject's physician for appropriate
safety measures to be taken.
Risk Classification:
The risks of this study are consistent with the HHS/FDA Regulations definition of minimal
risk.
Protection Against Risks:
The study PIs and the project manger who has a gerontology and public health background will
train the study recruiters, interviewers, and young volunteers to handle distressed or
potentially at risk patients during recruitment, intervention, and assessment. The
recruiters, interviewers, and young volunteers will request permission from distressed
subjects to notify their physician so that they may be assessed and treated as necessary. In
the case of emergengy, the recruiters, interviewers, and young volunteers will inform the
patient of the immediate need to notify the patient's physician, even without his or her
permission, so that these providers may take appropriate action to ensure patient safety.
This will involve using usual clinic channels to have the patient urgently evaluated and and
appropriate disposition arranged (including possible transport to Emergency Department in
Taipei and Hualien Tzu Chi Hospitals). The study principal investigator in the local site
will be available by cellular phone and will also be notified of emergency patients in order
to to ensure timely assessment and treatment by a physician.
Data Safety Monitoring Plan:
All assessment data will be entered into a centralized database located in the USC School of
Social Work. Study patients will be identified by a unique study code number, the identity of
which will be known only to the study personnel with direct responsibility for providing
patient data. The database will be password protected against non-project personnel and
backed up weekly. This removes patient-identifiable data from the files. The data manager and
biostatistician will create a series of databases in Excel and SAS, so that they can analyze
the initial data as it comes in to ensure proper patient recruitment, track progress of the
study, and perform data checks and cleaning. All baseline and follow-up data, including
responses to the screener questionnaire, will be entered on qualtrics web-based survey system
through tablets or other computer devices onsite. The data will be identified by the
patient's study ID code. This data will be transmitted either wirelessly, through third or
forth generation mobile telecommunications, or through the local network connection in real
time to the qualtrics server as data is entered by recruiters on the computer devices, which
has been loaded with the requisite software and encryption system. The transmitted data will
be encrypted using HIPAA-compliant encryption and password protected. If there is poor
wireless connection or mobile telecommunication transmission is not possible, recruiters will
enter baseline and follow-up data on paper forms. All forms will be checked for completeness
by the qualtric systems or, if paper, by the study coordinator before being sent to the
project manager. The project manager will review and double-check all of the forms to be sure
they are completed and readable. For data on paper forms, data will be entered singly using
SAS (SAS Institute Inc., SAS Campus Drive, Cary, NC) full screen editor (FSEDIT) into SAS
database system with back-up copy and hard copy kept in secure locked file cabinet in the
SSW. For data on the qualtrics server, data would be downloaded onto local sites into the SAS
database system with back-up copy password-protected. Accuracy of data entry will be ensured
by an internal program with FSEDIT for range and logic check, and by a comparison between
printouts and the handwritten data forms. To assist in monitoring the study, periodic reports
will be generated using graphs and tables summarizing the status of subject recruitment and
data collection. Missing data will be routinely rectified. SAS will also be used to analyze
the data and generate all statistical reports. Data on the qualtrics server and the project
website will be destroyed at the end of the study.
Potential Benefits to the Subject and/or Society:
Direct benefits to patients who participate IMTOP study include learning: 1) skills of tablet
use, 2) online community communication with family and friends, young volunteers, health care
providers, and diabetes peers who have similar condition/interest/ or disease, 3) diabetes
self-management knowledge and skills; and 4) mobile technology application to health access
and daily needs (i.e., online appointment, online refill, appointment reminder, online health
information, online training videos, and virtual classes such as e-newspaper, e-books,
related sites, apps) at no or minimal out-of-pocket cost (e.g., transportation cost to attend
the training course). There is a potential of improving the flow of communication between
these patients and their health educators as well as physicians through using mobile
technology. Self-management knowledge and behaviors will improve among them. Those patients
in the waitlist control group may also experience benefits due to the raised levels of
awareness of self-management, and later experience the potential benefits associated with the
tablet training intervention. The potential benefit to society is that IMTOP intervention is
likely to create an approach to improve self-management behaviors, health outcomes, and
quality of life in patients with type 2 diabetes. In addition, with improvement in
self-monitoring behavior among older diabetes patients and raised levels of health awareness
among young volunteers, medical expenses of diabetes care by the government might decrease,
which benefits the society as a whole.
Alternatives to Participation:
Refusal to participate will not negatively impact older adults' diabetes care or their access
to usually available health services. If patients are interested in learning more about
diabetes self-management skills, but do not wish to participate in the study, written
educational materials in Chinese will be available.
Refusal to participate among young adults, either in the volunteering group or in the
comparison group, also will not have any negative impact on the younger adults. They can
request to receive a copy of written educational materials in Chinese for future diabetes
prevention.
Risk/Benefit Relationship:
The potential benefits to participants are greater than the risks associated with
participation. The physical, psychological, social, and legal risks to patients with type 2
diabetes are minimal. IMTOP study aims to improve their health outcomes and quality of life.
In addition, the intergenerational interactions could be a motivator for them to learn the
technology to enhance their skills of self-management, which may result in improved health
and decreased cost of medical care as a whole.
For young volunteers, the risk is negligible but the focus of intergenerational interactions
could potentially improve their communication with and empathy for older adults, increase
awareness of self-care and disease prevention, build health-focused values of life style, and
shape future career choice.
For young adults in the comparison group, although both risk and benefit are minimal, they
may feel a sense of pride through their contribution to research.
