Trial Outcomes & Findings for Multiple Chronic Conditions for Older Adults (NCT NCT03387735)
NCT ID: NCT03387735
Last Updated: 2022-09-01
Results Overview
Quality of life is assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measure. For consistency with other measures, the time frame has been modified to refer to the past 2 weeks. Scores are calculated using the HealthMeasures Scoring Service. Scores are a T-score metric with a mean of 50 and a standard deviation of 10 with a range of about 20 to 80. Higher scores indicate better quality of life.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
346 participants
Primary outcome timeframe
Measured at baseline and 12 months
Results posted on
2022-09-01
Participant Flow
Recruitment was conducted from January 2018 to December 2019. The intervention period ended in June 2021.
Two participants signed the consent form and were randomized but did not start the study. One couldn't use the ET website due to macular degeneration. The other one decided he's not interested in using computers and ElderTree.
Participant milestones
| Measure |
Treatment as Usual (TAU) + Internet
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Overall Study
STARTED
|
168
|
176
|
|
Overall Study
COMPLETED
|
160
|
160
|
|
Overall Study
NOT COMPLETED
|
8
|
16
|
Reasons for withdrawal
| Measure |
Treatment as Usual (TAU) + Internet
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
|
Overall Study
Death
|
4
|
8
|
Baseline Characteristics
Multiple Chronic Conditions for Older Adults
Baseline characteristics by cohort
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
Total
n=344 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.54 years
STANDARD_DEVIATION 6.45 • n=5 Participants
|
75.03 years
STANDARD_DEVIATION 6.27 • n=7 Participants
|
74.79 years
STANDARD_DEVIATION 6.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
167 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
317 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=5 Participants
|
176 participants
n=7 Participants
|
344 participants
n=5 Participants
|
|
Health Insurance type
Medicare
|
57 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Health Insurance type
Medicaid
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Health Insurance type
Affordable Care Act
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health Insurance type
Military
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health Insurance type
Private insurance
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Health Insurance type
Covered under someone else
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health Insurance type
No insurance
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Health Insurance type
NA
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Health Insurance type
More than one source
|
105 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and 12 monthsQuality of life is assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measure. For consistency with other measures, the time frame has been modified to refer to the past 2 weeks. Scores are calculated using the HealthMeasures Scoring Service. Scores are a T-score metric with a mean of 50 and a standard deviation of 10 with a range of about 20 to 80. Higher scores indicate better quality of life.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
PROMIS Global Health Measure Score
Baseline: Mental
|
46.27 T-score
Standard Deviation 7.42
|
46.21 T-score
Standard Deviation 7.16
|
|
PROMIS Global Health Measure Score
12 Months: Mental
|
44.92 T-score
Standard Deviation 6.82
|
46.38 T-score
Standard Deviation 7.34
|
|
PROMIS Global Health Measure Score
Baseline: Physical
|
42.40 T-score
Standard Deviation 6.50
|
42.35 T-score
Standard Deviation 5.99
|
|
PROMIS Global Health Measure Score
12 Months: Physical
|
42.13 T-score
Standard Deviation 6.30
|
42.41 T-score
Standard Deviation 6.32
|
PRIMARY outcome
Timeframe: Baseline and 12-monthsPsychological well-being is assessed using the Psychological Flourishing Scale. The wording of items has been somewhat modified, including simplifying double-barreled items. For example, "I lead a purposeful and meaningful life" is shortened to "I lead a meaningful life." Scores are a sum of all items with a range from 8 to 40. Higher scores indicate a better well-being.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Psychological Flourishing Scale
Baseline
|
31.55 score on a scale
Standard Deviation 5.39
|
31.12 score on a scale
Standard Deviation 5.08
|
|
Psychological Flourishing Scale
12-months
|
31.50 score on a scale
Standard Deviation 5.15
|
31.48 score on a scale
Standard Deviation 5.60
|
PRIMARY outcome
Timeframe: Baseline and 12-monthsLoneliness is measured using the 8 items from the UCLA Loneliness Scale with the highest factor loadings among older adults. Scores ranged from 8 to 40. Higher scores indicate more loneliness.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
UCLA Loneliness Scale
12-months
|
16.05 score on a scale
Standard Deviation 6.27
|
16.75 score on a scale
Standard Deviation 5.86
|
|
UCLA Loneliness Scale
Baseline
|
16.02 score on a scale
Standard Deviation 5.77
|
17.12 score on a scale
Standard Deviation 6.04
|
SECONDARY outcome
Timeframe: 12-monthsLaboratory scores are obtained from the patient's electronic health record (EHR) including blood pressure, HAC1 for diabetes, cholesterol, BMI. Some participants did not have this data. The final score is a fraction of the number of unhealthy labs over each persons total labs. Scores range from 0 to 1. Higher scores indicate more unhealthy lab records.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=131 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=131 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Unhealthy Laboratory Scores
|
0.64 fraction of unhealthy lab scores
Standard Deviation 0.31
|
0.64 fraction of unhealthy lab scores
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline and 12-monthsFalls were assessed by asking how often the participant had fallen in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen. Falls ranged from 0 to 14.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Falls
Baseline
|
0.36 falls
Standard Deviation 0.95
|
0.36 falls
Standard Deviation 0.88
|
|
Falls
12-months
|
0.36 falls
Standard Deviation 0.89
|
0.72 falls
Standard Deviation 4.09
|
SECONDARY outcome
Timeframe: Baseline and 12-monthsSymptom distress is assessed using a combined list of 20 symptoms and chronic conditions from the General Symptom Distress Scale and Bayliss Disease Burden Scale, assessing the severity of distress for each over the past 2 weeks (0=do not have this, 1=not very distressing, and 5=extremely distressing). Scores range from 0 to 100. Higher scores indicate more symptom distress.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Symptom Distress
Baseline
|
21.10 score on a scale
Standard Deviation 14.56
|
20.58 score on a scale
Standard Deviation 14.55
|
|
Symptom Distress
12-months
|
18.86 score on a scale
Standard Deviation 14.89
|
18.58 score on a scale
Standard Deviation 14.14
|
SECONDARY outcome
Timeframe: Baseline and 12-monthsMedication adherence is assessed with 8 items, 6 based on the Brief Medication Questionnaire by Svarstad et al. We simplified response options so that participants rate how often they had specific issues with medication (1=never and 5=always). On the basis of patients' experiences, we added 2 original items, "Feels like I no longer need it" and "Feels like I don't need the full dose. There were 8 items in total, summed to get a final score. Scores ranged from 8 to 40. Higher scores indicate less medication adherence.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Medication Adherence
Baseline
|
13.14 score on a scale
Standard Deviation 4.36
|
13.07 score on a scale
Standard Deviation 3.88
|
|
Medication Adherence
12-months
|
12.70 score on a scale
Standard Deviation 4.23
|
12.56 score on a scale
Standard Deviation 4.07
|
SECONDARY outcome
Timeframe: Baseline and 12-monthsCrisis health care was the total number of urgent care visits, emergency room visits, and hospitalizations combined. Reported is the average count of visits. Higher numbers indicate more visits.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Crisis Health Care Visits
Baseline
|
0.42 visits
Standard Deviation 0.90
|
0.45 visits
Standard Deviation 1.06
|
|
Crisis Health Care Visits
12-months
|
0.86 visits
Standard Deviation 1.76
|
0.76 visits
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Baseline and 12-monthsLong-term care was the number of nights spent in assisted living facilities and nursing homes over the past 3 months. Number of nights ranged from 0 to 92. Higher numbers indicate more nights spent.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Long-term Care
Baseline
|
0.01 nights
Standard Deviation 0.15
|
0.25 nights
Standard Deviation 2.50
|
|
Long-term Care
12-months
|
0.79 nights
Standard Deviation 7.76
|
0.29 nights
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Baseline and 12-monthsFalls requiring medical attention was assessed by one item counting the number of times in the past 3 months. A fall is defined in the survey as "the body going to the ground without being pushed." Here we report statistics for how many times participants had fallen and required medical attention. Falls needing medical attention ranged from 0 to 4.
Outcome measures
| Measure |
Treatment as Usual (TAU) + Internet
n=168 Participants
Patients will be given access to helpful websites such as National Institute on Aging.
Treatment as usual (TAU) + Internet: Patients in this group will receive TAU+internet and links to helpful websites.
|
Treatment as Usual (TAU) + ElderTree
n=176 Participants
Patients will be given access to the ElderTree website for 12 months which provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
TAU + ElderTree: For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits.
|
|---|---|---|
|
Falls Requiring Medical Attention
Baseline
|
0.23 falls requiring medical attention
Standard Deviation 0.50
|
0.18 falls requiring medical attention
Standard Deviation 0.39
|
|
Falls Requiring Medical Attention
12-months
|
0.33 falls requiring medical attention
Standard Deviation 0.84
|
0.16 falls requiring medical attention
Standard Deviation 0.37
|
Adverse Events
Treatment as Usual (TAU) + Internet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Treatment as Usual (TAU) + ElderTree
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place