Collaborative Care With Smart Health Management Program for Patients With Chronic Illness
The Effectiveness of Collaborative Care With Smart Health Management Program for Patients With Chronic Illness: Randomized Controlled Trial
1 other identifier
interventional
54
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
September 26, 2017
CompletedStudy Start
First participant enrolled
October 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedMarch 17, 2021
March 1, 2021
7 months
September 19, 2017
March 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression
Improvement of depression (PHQ-9)
Baseline, 3 months post-intervention
Secondary Outcomes (6)
Health behavior patterns
Baseline, 3 months post-intervention
Health Management Strategies
Baseline, 3 months post-intervention
Quality of life (Mcgill QoL)
Baseline, 3 months post-intervention
Quality of life (EuroQoL)
Baseline, 3 months post-intervention
Quality of life (SF-12)
Baseline, 3 months post-intervention
- +1 more secondary outcomes
Study Arms (3)
ICT programs + Tele-coaching programs
EXPERIMENTALICT 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.
ICT programs
EXPERIMENTALICT 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.
A book about chronic disease
ACTIVE COMPARATORSubjects in the group get a book about chronic disease for patients. After 3 months, they finish reading the materials, they fill out the questionnaire.
Interventions
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.
ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)
A Take-home book about chronic disease are provided for self-education
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Korea Health Industry Development Institutecollaborator
- National Evidence-Based Healthcare Collaborating Agencycollaborator
- National Institute of Health, Koreacollaborator
- National Clinical Research Coordination Center, Seoul, Koreacollaborator
- Seoul National University Bundang Hospitalcollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
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.
PMID: 33674921DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Ho Yun, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 19, 2017
First Posted
September 26, 2017
Study Start
October 27, 2017
Primary Completion
June 7, 2018
Study Completion
June 30, 2019
Last Updated
March 17, 2021
Record last verified: 2021-03