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CompletedNCT03294057Updated Mar 17, 2021

Collaborative Care With Smart Health Management Program for Patients With Chronic Illness

An interventional study of Tele-coaching programs and ICT programs in Osteoporosis, Chronic Respiratory Disease and Arthritis, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

This study verifies efficacy of collaborative care with Smart Health Management Program developed for patients with chronic illness. The aim of the study is to observe the changes in clinical indicators, quality of life and health related behaviors when providing self-management programs with ICT for chronic disease patients.

Read the detailed description

This study is to demonstrate that chronic disease patients receiving collaborative care with ICT-based self-management and educational program can improve clinical outcomes and overall health status, including quality of life and health habits.

In addition to the economic burden, people with chronic disease experience various psychosocial crises such as anxiety and depression, which causes the deterioration of overall quality of life and increases social burden. The collaborative care management based Chronic Care Model (CCM) have provided coaching by a medically supervised nurse, working with each patient's physician. However, standard CCM have limitations in that they do not provide self-management strategies of the patient in detail. Therefore, to improve the effectiveness of the CCM model, it is required to propose a new approach to the utilization of IT-based self-management program that is currently being developed to increase accessibility and efficiency of health care service.

Primary outcomes of this study are as follow: Improvement of depression in patients with osteoporosis, chronic respiratory disease and chronic arthritis.

Participants in this study will respond a baseline questionnaire about depressive mood, health habits, health behavior patterns and quality of life, diet, exercise, etc. After that, participants will be allocated equally into three groups - the intervention group 1, intervention group 2 and the control group. The intervention group 1 will receive S Healthing and a tele- coaching program conducted 12 times (one time for one week), and more than 20 minutes each by a trained nurse. The intervention group 2 will receive S Healthing while the control group will receive basic educational material on the disease. Coaching content consists specifically of: 1) evaluation, 2) facing and accepting the health crisis, 3) setting up new goals, 4) making decisions and plans, and 5) practice. "S Healthing" is based ICT- program and includes educational contents and self-management program based on Smart Management Strategy for Health (SMASH). The intervention group 1, 2 will conduct self-management for 3 months through smart phone application and web program. Participants will receive a questionnaire about the quality of life and health habits with the clinical examination 3 months after baseline survey was conducted. The result from two questionnaires (baseline, 3 months post-intervention) and clinical outcome of baseline and 3 months will be compiled and be compared with others.

02

Conditions studied

  • Osteoporosis
  • Chronic Respiratory Disease
  • Arthritis
  • Osteopenia

Keywords

  • Self-Management IT Program
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject 19 years old and more
  • Subject who understands the purpose of the study and signs with informed consent form
  • Subject with chronic disease (osteoporosis, chronic pulmonary disease, chronic arthritis)
  • Subject with METs less than 12.5 hours per week
  • Subjects who use smart phones and PCs (those who can use ICT-based health care programs)

Exclusion criteria

Exclusion Criteria:

  • Inability to speak, understand, or write Korean
  • Inability to understand the contents of the provided materials due to poor eyesight and hearing
  • Medical conditions that would limit adherence to participation of the clinical trial (as confirmed by their referring physician; e.g. dyspnea, severe depression and other mental disorders)
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    ICT programs + Tele-coaching programs

    ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH) are provided. And a trained nurse provides tele-coaching programs to subjects. After that, subjects will conduct self-management health care and tele-coaching programs for 12 weeks. After 3 months, they finish self-management ICT + coaching programs, and then they fill out the questionnaire.

    Behavioral: Tele-coaching programs · Behavioral: ICT programs

  • Experimental
    ICT programs

    ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH) are provided. After that, subjects will conduct self-management health care for 12 weeks. After 3 months, they finish self-management ICT programs, and then they fill out the questionnaire.

    Behavioral: ICT programs

  • Active comparator
    A book about chronic disease

    Subjects in the group get a book about chronic disease for patients. After 3 months, they finish reading the materials, they fill out the questionnaire.

    Behavioral: A book about chronic disease

Interventions

  • BehavioralTele-coaching programs

    Tele-coaching program conducted 12 times (one time for one week), and more than 20 minutes each by a trained nurse. Coaching content specifically, 1) evaluation, 2) facing and accepting the health crisis, 3) setting up new goals, 4) making decisions and plans, and 5) practice.

  • BehavioralICT programs

    ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)

  • BehavioralA book about chronic disease

    A Take-home book about chronic disease are provided for self-education

05

What researchers measure

Primary outcomes

  1. Depression

    Improvement of depression (PHQ-9)

    Time frame: Baseline, 3 months post-intervention

Secondary outcomes

  1. Health behavior patterns

    We identify health habits by dividing into five steps according to the TTM stage. We evaluate Increase in maintenance rate of health behavior patterns.

    Time frame: Baseline, 3 months post-intervention

  2. Health Management Strategies

    Improvement of Health Management Strategies by SAT (We use Smart Management Strategy for Health Assessment Tool (SAT) to assess their self-management (SM) strategies of health by themselves).

    Time frame: Baseline, 3 months post-intervention

  3. Quality of life (Mcgill QoL)

    Improvement of quality of life (Mcgill QoL)

    Time frame: Baseline, 3 months post-intervention

  4. Quality of life (EuroQoL)

    Improvement of quality of life (EuroQoL)

    Time frame: Baseline, 3 months post-intervention

  5. Quality of life (SF-12)

    Improvement of quality of life (SF-12)

    Time frame: Baseline, 3 months post-intervention

  6. Physical activity

    Changes in exercise (Godin's Leisure Time Exercise Questionnaire)

    Time frame: Baseline, 3 months post-intervention

06

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
07

References and documents

Publications

  • Kang E, Park SM, Lee K, Lee EB, Yim JJ, Lee J, Kim S, Rhee YE, Yun YH. Efficacy of Health Coaching and an Electronic Health Management Program: Randomized Controlled Trial. J Gen Intern Med. 2021 Sep;36(9):2692-2699. doi: 10.1007/s11606-021-06671-2. Epub 2021 Mar 5. PubMed 33674921 ↗
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Registry details

Key details

Study ID
NCT03294057
Lead sponsor
Seoul National University Hospital
Collaborators
Korea Health Industry Development Institute, National Evidence-Based Healthcare Collaborating Agency, National Institute of Health, Korea, National Clinical Research Coordination Center, Seoul, Korea, Seoul National University Bundang Hospital
Responsible party
Young Ho Yun (Principal Investigator, Seoul National University Hospital) — Principal investigator
First posted
Sep 26, 2017
Start date
Oct 27, 2017
Primary completion
Jun 7, 2018
Completion
Jun 30, 2019
Last update
Mar 17, 2021

Study contacts

Young Ho Yun, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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