NCT07754994

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Oct 2026

Status
not yet recruiting

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

July 9, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

August 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

July 9, 2026

Last Update Submit

August 7, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Self-regulation Measured by Adapted Short Self-Regulation Questionnaire (SSRQ)

    A 31-item measure of the ability to regulate behavior in order to achieve desired future outcomes.

    Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention

  • Change in Medication Usage Self-efficacy Measured by Medication Usage Self-Efficacy (MUSE) questionnaire

    A brief 8-item tool that measures how confident a person is in understanding and taking their prescribed medications.

    Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention

  • Change in Medication Usage Self-efficacy Measured by Medication Adherence Self-Efficacy Scale-revised (MASES-R)

    A13-item questionnaire that measures a person's confidence in taking their medication even when faced with difficult situations.

    Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention

Study Arms (2)

bpMedManage R Immediate Group

EXPERIMENTAL

Participants will first complete a 4 week baseline medication adherence monitoring period followed by 8 weeks of intervention.

Other: Immediate Intervention Arm

bpMedManage R Delayed Group

OTHER

Participants will first complete a 12 week of baseline medication adherence monitoring period followed by 8 week of intervention.

Other: Delayed Intervention Arm

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.

bpMedManage R Immediate Group

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.

bpMedManage R Delayed Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of dementia
  • Major communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2026

First Posted

August 10, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

August 10, 2026

Record last verified: 2026-06