Mild Cognitive Impairment (MCI)
Conditions
Brief summary
The goal of this feasibility study is to evaluate the preliminary impact of a mobile health application (app) called bpMedManage-R, designed to support hypertension medication self-management in persons with mild cognitive impairment (PwMCI) who live alone. The main questions this study aims to answer are whether the bpMedManage-R app shows preliminary impact on medication-related self-regulation (the ability to consistently take medications as prescribed) and self-efficacy (confidence in independently managing medication use). Participants will be randomized after a baseline assessment to the bpMedManage-R Immediate Group or the bpMedManage-R Delayed Group. Participants assigned to the Immediate Group will complete a 4-week baseline adherence period, at the end of which they will enter the intervention phase. A remote training session will be conducted to initiate the intervention phase, during which participants will download the app, learn to use it, and set up their medication schedule and reminders within the app with support from the study team. They will then use the app for 8 weeks to self-manage their medications, take part in brief weekly check-ins to review progress, and complete Outcome Assessment 1 at the end of the 8-week intervention phase. Participants assigned to the Delayed Group will complete a 12-week baseline adherence period, at the end of which they will complete Outcome Assessment 1. Subsequently, they will enter the intervention phase and will follow a process similar to that of the Immediate Group. At the end of the 8-week intervention phase, they will complete Outcome Assessment 2. Researchers will compare participants who receive the bpMedManage-R app intervention immediately to those assigned to the delayed control group.
Interventions
Participants will first complete a 4 week baseline medication adherence monitoring period. After this period, they will attend a video conferencing session with the research team to receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks to monitor their medication adherence along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, participants will complete a final assessment.
OTHERDelayed Intervention Arm
Participants will first complete a 12 week baseline medication adherence monitoring period. At the end of this period, they will attend a video conferencing session with the research team during which they will complete a brief assessment and receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks, along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, they will complete a final assessment.
Sponsors
University of Illinois at Urbana-Champaign
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 60+ * Fluent in English * Adequate visual and auditory acuity * Community dwelling * Lives alone * Self-reported memory problems * Manage at least one hypertension medication * Passing score on Telephone Interview for Cognitive Status - Modified (TICS- M) between 27-37 * Passing score on Montreal Cognitive Assessment (MoCA) between 20 and 26 * Geriatric Depression Scale (GDS) score of 6 or lower * Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
* Diagnosis of dementia * Major communication difficulties
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-regulation Measured by Adapted Short Self-Regulation Questionnaire (SSRQ) | Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention | A 31-item measure of the ability to regulate behavior in order to achieve desired future outcomes. |
| Change in Medication Usage Self-efficacy Measured by Medication Usage Self-Efficacy (MUSE) questionnaire | Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention | A brief 8-item tool that measures how confident a person is in understanding and taking their prescribed medications. |
| Change in Medication Usage Self-efficacy Measured by Medication Adherence Self-Efficacy Scale-revised (MASES-R) | Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention | A13-item questionnaire that measures a person's confidence in taking their medication even when faced with difficult situations. |
Contacts
CONTACTRaksha Mudar
Outcome results
None listed