NCT02971241

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
617

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

November 19, 2016

Last Update Submit

May 3, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

IntegenerationMobile technologyChronic disease managementDiabetes self-management

Outcome Measures

Primary Outcomes (2)

  • Patient survey

    The survey collects data from patients include demographic characteristics, relationship with children and grandchildren, physical health (IADL) and mental health status, self-management behaviors, health care utilization and satisfaction, health literacy, self-efficacy, usage of app, social engagement, attitudes toward young adults and quality of life.

    One year

  • Young students survey

    The survey will collect data about demographic characteristics, level of empathy, citizenship behavior, time management skills, altruism value, purpose of life, attitudes toward older adults, relationship with grandparents and career development.

    Four month

Study Arms (2)

Immediate intervention group

EXPERIMENTAL

A randomized, waitlist controlled trial with three hundred fifty older adult subjects with type 2 diabetes and 280 young adult subjects will be conducted in Taipei Tzu Chi Hospital and Hualien Tzu Chi Hospital in Taiwan. 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 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 with a lead instructor.

Behavioral: Intergenerational Mobile Technology Opportunities Program

Waitlist control group

OTHER

The patients randomized to the waitlist control group will need to wait for four months to serve as no intervention control, and then assigned to the training course.

Behavioral: Intergenerational Mobile Technology Opportunities Program

Interventions

Intergenerational Mobile Technology Opportunities ProgramBEHAVIORAL

The themes of the 8-week training session are designed based on the objectives of IMTOP: 1) teach skills of tablet use and diabetes self-management behavior tracking app, 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).

Immediate intervention groupWaitlist control group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current Taipei or Hualien Tzu Chi patients
  • aged equal to or greater than 55 years
  • having a current diagnosis of type 2 diabetes mellitus with duration of diagnosis at least 6 months
  • having the ability of reading Chinese newspaper
  • normal eye-hand coordination
  • being able to regularly attend the IMTOP training course
  • understanding Mandarin (listening, speaking, reading, and writing).
  • having a working telephone at home or a cellular phone.
  • age between 18 and 30
  • having basic levels of verbal, interpersonal communication, and computer skills and commitment in voluntary works for approximately 50 hours during the period of intervention.

You may not qualify if:

  • a score of 2 or greater on the CAGE 4M alcohol assessment;
  • having schizophrenia, schizoaffective disorder, manic-depressive, or needing lithium;
  • cognitive impairment precluding ability to give informed consent or participating in the intervention, i.e., SPMSQ score of 4 or more errors.
  • age less than 18 or above 30
  • being unfamiliar with computer
  • being unable to commit 50 hours during the period of intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HualienTzu Chi Hospital

Hualien City, Taiwan

Location

Taipei Tzu Chi Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • International Diabetes Federation (2013). Diabetes: Facts and Figures. Retrieved from http://www.idf.org/worlddiabetesday/toolkit/gp/facts-figures Santos-Longhurst, A. (2014). Type 2 Diabetes Statistics and Facts. Retrieved from http://www.healthline.com/health/type-2-diabetes/statistics#2 Gregg, E. W., Mangione, C. M., Cauley, J. A., Thompson, T. J., Schwartz, A. V., Ensrud, K. E., & Nevitt, M. C. (2002). Diabetes and incidence of functional disability in older women. Diabetes Care, 25(1), 61-67. Gregg, E. W., Breckles, G. L. A., Williamson, D. E., Leveille, S. G., Langlois, J. A., Engelgau, M. M., Venkat Narayan, K. M. (2000). Diabetes and physical disability among older U.S. adults. Diabetes Care, 23(9), 1272-1277. Gregg, E. W., Breckles, G. L. A., Williamson, D. E., Leveille, S. G., Langlois, J. A., Engelgau, M. M., Venkat Narayan, K. M. (2000). Diabetes and physical disability among older U.S. adults. Diabetes Care, 23(9), 1272-1277. Glasgow, R. E., Kurz, D., King, D., Faber, A. J., Halterman, E., Woolley, T. Toobert, D. J., Strycker, L. A., Estabrooks, P. A., Osuna, D., & Ritzwoller, D. (2012). Twelve-month outcomes of an internet-based diabetes self-management support program. Patient Education and Counseling, 87, 81-92 Yo, N. C. (2014). One in every ten people is living with diabetes mellitus. Retrieved from http://www.tpuca.org/news_list/show/316.html World People News. (2014). Diabetes has been ranked as the fourth leading causes of death in Taiwan. Retrieved from http://www.worldpeoplenews.com/category/2/6 Ministry of Health and Welfare. (2014). Diabetes shared network. Retrieved from http://www.tpuca.org/news_list/show/316.html

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shinyi Wu, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Quasi-experimental wait-listed control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 19, 2016

First Posted

November 22, 2016

Study Start

October 1, 2015

Primary Completion

May 1, 2017

Study Completion

April 1, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

Locations

TW(2)