Clinical trial NCT04682977: Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline
Official title: Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease)
Uncontrolled Diabetes (HBA1c ≥ 10)
Keywords: chronic disease
aging
physical function
executive function
activities of daily living
primary care
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-12-24
Enrollment: 45
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive the IPROACTIF intervention or usual primary care services. Stratified randomization will be carried out with each diagnostic category (diabetes and heart disease) serving as a stratum.
Primary purpose: PREVENTION

Brief summary: Conduct a pilot randomized control to assess the preliminary efficacy of IPROACTIF, an occupational therapist-delivered primary care intervention for aging and chronic disease management.

Detailed description: The IPROACTIF intervention is based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease. The 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning. This pilot randomized control trial will compare whether patients who receive IPROACTIF perform better than usual care patients on physical functioning, self-efficacy for chronic disease management, physical activity levels, executive functioning, health-related quality of life, and participation in life roles and activities.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Community-dwelling
* 55 years of age
* Primary diagnosis of heart disease (coronary artery disease, ischemic heart disease, hypertensive heart disease), or uncontrolled diabetes (HBA1c greater than/equal to 10)
* Self-reported risk of functional decline (score of 3 or higher) on the 11-item Brief Risk Identification of Geriatric Health Tool or self-reported need for assistance with disease management

Exclusion Criteria

* Current/past diagnosis of stroke or other neurological disorders
* Receiving pharmacological treatment for cognition
* Participating in other exercise or ADL-focused intervention studies
* Non-English speaking
* Residing in a long-term care institution
* Compromised decision-making capacity (score \>8 on SOMCT)

Primary outcomes:
measure: Physical functioning measured using the PROMIS Physical Function Short Form 20
timeFrame: 12 weeks
measure: Physical functioning measured using the Patient-Specific Functional Scale
timeFrame: 12 weeks
measure: Physical functioning measured using the Physical Performance Test (9-item)
timeFrame: 12 weeks
measure: Performance of daily living tasks using the Performance Assessment of Self-care Skills
timeFrame: 12 weeks
measure: Executive functioning using the Dimensional Change Card Sort Test
timeFrame: 12 weeks
measure: Executive functioning using the Executive Function Performance Test
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical activity level
timeFrame: 12 weeks
measure: Self-efficacy for chronic disease management using the Chronic Disease Self-Efficacy and Self-Management Measures
timeFrame: 12 weeks
measure: Health related quality of life using the PROMIS Global Health Measure (physical and mental subscales)
timeFrame: 12 weeks
measure: Participation in life activities and roles using the Late Life Functioning and Disability Index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Mansha Mirza, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: