Trial Outcomes & Findings for A Mobile Informatics Solution to Aid in Memory (NCT NCT04700540)
NCT ID: NCT04700540
Last Updated: 2025-03-26
Results Overview
Original three-item measure, including: * How often do you feel you lack companionship? * How often do you feel left out? * How often do you feel isolated from others? Scale range 3-9, higher scores indicate higher rates of social isolation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
3 months
Results posted on
2025-03-26
Participant Flow
81 caregivers consented and 81 persons with memory concerns consented or assented to be part of the study, totaling 162 participants or 81 dyads. Six participants or 3 dyads withdrew before randomization. Data is reported for the 156 randomized participants.
Participant milestones
| Measure |
Intervention Group
The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline, 3 months and 6 months following enrollment.
Smartwatch Reminder (SR) system: The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
|
Attention Control Group
Care partners are administered surveys at baseline, 3 months and 6 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months and 6-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
72
|
|
Overall Study
COMPLETED
|
44
|
64
|
|
Overall Study
NOT COMPLETED
|
40
|
8
|
Reasons for withdrawal
| Measure |
Intervention Group
The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline, 3 months and 6 months following enrollment.
Smartwatch Reminder (SR) system: The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
|
Attention Control Group
Care partners are administered surveys at baseline, 3 months and 6 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months and 6-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
8
|
|
Overall Study
Participant wished to discontinue intervention use, but remained in study to complete surveys only.
|
28
|
0
|
Baseline Characteristics
A Mobile Informatics Solution to Aid in Memory
Baseline characteristics by cohort
| Measure |
Intervention Group
n=84 Participants
The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline, 3 months and 6 months following enrollment.
Smartwatch Reminder (SR) system: The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
|
Attention Control Group
n=72 Participants
Care partners are administered surveys at baseline, 3 months and 6 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months and 6-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
69.9 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsOriginal three-item measure, including: * How often do you feel you lack companionship? * How often do you feel left out? * How often do you feel isolated from others? Scale range 3-9, higher scores indicate higher rates of social isolation.
Outcome measures
| Measure |
Intervention Group
n=28 Participants
The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline and 3 months following enrollment.
Smartwatch Reminder (SR) system: The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
|
Attention Control Group
n=31 Participants
Care partners are administered surveys at baseline and 3 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time.
|
|---|---|---|
|
PWMC Loneliness
|
4.90 units on a scale
Interval 4.23 to 5.13
|
5.28 units on a scale
Interval 4.63 to 5.53
|
PRIMARY outcome
Timeframe: 3 monthsThe Lubben Social Network Scale (LSNS) is a measure of social relationships and social support networks. We used the shortened 6-item scale to reduce test burden. The 6-item scale has a range of 0 - 30 with higher scores indicating more robust social networks / access to support.
Outcome measures
| Measure |
Intervention Group
n=28 Participants
The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline and 3 months following enrollment.
Smartwatch Reminder (SR) system: The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
|
Attention Control Group
n=31 Participants
Care partners are administered surveys at baseline and 3 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time.
|
|---|---|---|
|
PWMC Social Relationships and Social Support
|
13.50 units on a scale
Interval 11.7 to 15.3
|
10.72 units on a scale
Interval 8.92 to 12.52
|
SECONDARY outcome
Timeframe: 3 monthsWe used the Global Health Scale. This tool is designed to assess an individual's overall physical and mental wellbeing. The scale measures subjective health perceptions. Scale scores range from 0 - 100, with higher scores indicating higher rates of mental and physical well-being.
Outcome measures
| Measure |
Intervention Group
n=28 Participants
The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline and 3 months following enrollment.
Smartwatch Reminder (SR) system: The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
|
Attention Control Group
n=31 Participants
Care partners are administered surveys at baseline and 3 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time.
|
|---|---|---|
|
PWMC Physical and Mental Well-being
|
32.69 score on a scale
Interval 26.68 to 38.7
|
32.72 score on a scale
Interval 26.71 to 38.73
|
Adverse Events
Intervention Group
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Attention Control Group
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Group
n=84 participants at risk
The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline, 3 months and 6 months following enrollment.
Smartwatch Reminder (SR) system: The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
|
Attention Control Group
n=72 participants at risk
Care partners are administered surveys at baseline, 3 months and 6 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months and 6-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time.
|
|---|---|---|
|
Cardiac disorders
Person with Memory Concerns Stroke
|
1.2%
1/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
1.4%
1/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
1.4%
1/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
Other adverse events
| Measure |
Intervention Group
n=84 participants at risk
The PWMC and Care partner in this group will receive the SR. The project will provide a smartwatch and smartphone for the dyads in the study. All others (family, friends, etc.) will be able to download a smartphone app from an online store. Instructional material will be created to show the suggested information that can be entered into the app. Care partners and PWMC are administered surveys at baseline, 3 months and 6 months following enrollment.
Smartwatch Reminder (SR) system: The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
|
Attention Control Group
n=72 participants at risk
Care partners are administered surveys at baseline, 3 months and 6 months following enrollment. The attention control group will receive a contact call from one of the researchers 3-months and 6-months after enrollment. Based on our prior experience, PWMC and care partners in an attention control group will often seek information and psychosocial support during these calls. We will provide free information resources (e.g., brochures or websites of the Alzheimer's Association) at that time.
|
|---|---|---|
|
Vascular disorders
Diabetes hospitalization
|
1.2%
1/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
0.00%
0/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Injury, poisoning and procedural complications
PWMC Fractured Pelvis
|
1.2%
1/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
0.00%
0/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Injury, poisoning and procedural complications
Weather related fall
|
1.2%
1/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
0.00%
0/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Cardiac disorders
Low blood pressure
|
1.2%
1/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
0.00%
0/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Eye disorders
Eye Surgery
|
1.2%
1/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
0.00%
0/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Musculoskeletal and connective tissue disorders
Knee replacement
|
0.00%
0/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
1.4%
1/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Musculoskeletal and connective tissue disorders
Back surgery
|
0.00%
0/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
1.4%
1/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Congenital, familial and genetic disorders
PWMC Instability and memory concerns
|
0.00%
0/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
1.4%
1/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Infections and infestations
Person with memory concerns flu
|
0.00%
0/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
1.4%
1/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
|
Blood and lymphatic system disorders
Sepsis
|
0.00%
0/84 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
1.4%
1/72 • Adverse events were documented during study enrollment (following consent through final data collection). Participants were enrolled for about 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place