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동기심리 기반 스마트 참여 시스템 (MOSES)

2026년 9월 28일 업데이트: Baltimore Research & Education Foundation, Inc.

고령자 만성질환 관리 개선을 위한 동기심리 기반 스마트 참여 시스템 원문보기 KCI 원문보기 인용

In 2010, 25.8 million people in the US, or 8.3% of the population were reported to have diabetes. Type 2 diabetes mellitus (T2DM) is especially prevalent among older adults: 26.9% of people 65 years or older have diabetes with 50% being pre-diabetic. Diabetes is the leading cause of blindness, kidney disease and lower-limb amputation among older adults, and is also a major risk factor for cardiovascular disease.

Fortunately, diabetes and its related complications are very amenable to lifestyle changes. Engagement with healthcare providers can significantly affects behavior and disease management of practices of individuals as does social engagement. The use of mobile technology and better engagement with providers and peer support networks may support diabetes self-care management. Individual patient personality attributes may affect the success of technology interventions.

In this study, the investigators propose to design and test a motivation psychology-based smart engagement system (MOSES), which is a software application on a digital tablet device. The pre-loaded tablets will be provided to adults with T2DM (age 60+ with high glucose). The software will allow the patients to record diabetes self-care activities (exercise, glucose, nutrition, medication adherence), pursue goals, support communication between the patient and a health coach, support communication between peer patients, and visualize health status more easily by patients and providers. This research program will enroll 88 patients (4 intervention groups of 12 persons each and a 40-person control group) in a 90-day pilot study to test and refine the design of the application and its effectiveness in supporting care plan goals.

Primary Aim 1: Design, implement, and optimize a motivation psychology-based smart engagement system (MOSES) for older adults with diabetes.

Secondary Aim 2: Determine if providing older adult diabetic patients to care managers and peers via a digital tablet-based software application leads to improved diabetes management as measured by blood glucose control.

Secondary Aim 3: Refine the personality attributes used to tailor the interaction with the application.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The investigators propose to conduct a 90-day pilot study to establish the effects and value of MOSES in the management of diabetes. The pilot study will provide initial data to answer the following research questions: (1) What are the effects of MOSES technology on older adults' diabetes self-care? (2) What type of social engagement intervention is more effective for what aspects of diabetes care? (3) What personality characteristics predict older adults' diabetes self-care?; (4) What personality characteristics moderate the effectiveness of mobile device (esp. tablet-based) social engagement interventions on older adults' diabetic care? (5) What model can be developed from our data to predict probability of effective response to interventions tailored to individual patients, e.g. by message type for clinical, usage and personality attributes?

Subjects Older adults are the target population for this study. Adult volunteers age 60 and above with an HbA1C of >7.9% and having the capacity to provide informed consent will be eligible to participate. Participants will be randomized to usual care or to an intervention group (described below). Once enrolled in the study and randomized to either the intervention or the control group, the Research Certified Diabetes Educator (CDE) will review all participants' clinical data and assist with providing feedback messages to the participants regarding their self-care progress. The Research CDE will alert physicians to any clinical data that would warrant a change in clinical management (e.g. hyper or hypoglycemia).

Manipulations

There are four manipulations in the experiment: (1) patient recording i.e. using the tablet and app to track and review progress (this increases mindfulness, engagement, activation, and informedness, thereby leading to healthier behaviors than the control condition), (2) patient recording with physician involvement via Health-feed communication messages (in addition to the benefits listed above, this provides expert feedback from a trusted source on actions, helps with goal setting, provides motivational reinforcement of positive behavior and sanction against negative, etc.), (3) patient recording with peer interaction i.e. using Health-feed messages, Community Views and Health Tournaments (in addition to the benefits listed for (1), peer effects have been observed in a variety of different settings such as educational attainment). People tend to emulate the behavior of peers, setting in motion a cycle of group conformism. People may also be motivated by a desire to compete in a peer setting, and (4) patient recording with peer interaction AND physician involvement. This final group will permit analysis of the interaction effects of the two forms of social engagement. Thus, the experiment will be done with the following groups:

  • Group A: the control group, usual care, (n=40)
  • Group B: individual patients using app w/o provider support (n=12)
  • Group C: individual patients using app w/ provider support (n=12)
  • Group D: peer patient teams using app w/o provider support (n=12; 4 teams)
  • Group E: peer patient teams using app with provider support (n=12; 4 teams)

Groups will be assigned to achieve age, gender and HbA1C matching at baseline. For groups with provider engagement (E), the provider (endocrinologist/CDE) will provide initial advice to the subjects, as well as continuous monitoring. The study will require a dedicated diabetes educator, who will spend 2 hours a day to keep in touch with the subjects, including reviewing the activity logs, sending reminder and motivational messages, as well as moderating the discussions in the peer engagement group. The CDE will triage the text messages from subjects and trigger the physician engagement when necessary. The study CDE will review participant data routinely and will maintain communication with the study team on a timely basis.

During the experiments, adverse events will be closely monitored by the physician and CDE, as well as through subject self-reports. The MOSES app has a built-in function to highlight potential adverse effects in the activity list and physician to-do list. The investigators will also conduct a weekly review of subject activity log.

연구 유형

중재적

등록 (실제)

88

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • Baltimore VA Maryland Health Care System

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

60년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Veterans 60 years of age and older with an HbA1c of >7.9%
  • Recieving routine medical care within the University of Maryland Medical Center Midtown Campus (UMMCMC) who are 60 years of age and older with HbA1c of >7.9%

Exclusion Criteria:

  • Unable to provide informed consent
  • Blindness
  • Deaf
  • Type I DM
  • Active Serious Mental Illness
  • Homelessness

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Standard of Care Group - A

The control group

활성 비교기: MOSES - Group B

Individual patients using application and pedometer without healthcare provider support

MOSES is an integrated system between a patient, peer patients, and healthcare providers.

다른 이름들:
  • 동기심리 기반 스마트 참여 시스템
활성 비교기: MOSES - Group C

Individual patients using application and pedometer with healthcare provider support

MOSES is an integrated system between a patient, peer patients, and healthcare providers.

다른 이름들:
  • 동기심리 기반 스마트 참여 시스템
활성 비교기: MOSES - Group D

Peer patient teams using application and pedometer without healthcare provider support

MOSES is an integrated system between a patient, peer patients, and healthcare providers.

다른 이름들:
  • 동기심리 기반 스마트 참여 시스템
활성 비교기: MOSES - Group E

Peer patient teams using application and pedometer with healthcare provider support

MOSES is an integrated system between a patient, peer patients, and healthcare providers.

다른 이름들:
  • 동기심리 기반 스마트 참여 시스템

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
헤모글로빈 A1c 개선
기간: 3 개월
3 개월

2차 결과 측정

결과 측정
기간
당뇨병 관리 계획 준수
기간: 3 개월
3 개월

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Nanette Steinle, MD, Baltimore VA Maryland Health Care System

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 6월 1일

기본 완료 (실제)

2020년 10월 12일

연구 완료 (실제)

2020년 10월 12일

연구 등록 날짜

최초 제출

2014년 4월 29일

QC 기준을 충족하는 최초 제출

2014년 4월 29일

처음 게시됨 (추정된)

2014년 4월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 28일

마지막으로 확인됨

2020년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CHIDS-MOSES

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .