Motivační systém inteligentního zapojení založený na psychologii (MOSES)
Systém inteligentního zapojení motivace založený na psychologii pro lepší zvládání chronických onemocnění starších dospělých
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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- Baltimore VA Maryland Health Care System
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Žádný zásah: Standard of Care Group - A
The control group |
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Aktivní komparátor: 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.
Ostatní jména:
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Aktivní komparátor: 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.
Ostatní jména:
|
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Aktivní komparátor: 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.
Ostatní jména:
|
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Aktivní komparátor: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Zlepšení hemoglobinu A1c
Časové okno: 3 měsíce
|
3 měsíce
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Dodržování plánu péče o cukrovku
Časové okno: 3 měsíce
|
3 měsíce
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Nanette Steinle, MD, Baltimore VA Maryland Health Care System
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhadovaný)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- CHIDS-MOSES
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