Multiple Chronic Conditions for Older Adults

Heart-Related Multiple Chronic Conditions in Primary Care: Behavioral Technology

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03387735

Enrollment

346

Registered

2018-01-02

Start date

2018-01-01

Completion date

2021-06-29

Last updated

2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

Keywords

Hypertension, Hyperlipidemia, Diabetes, Arthritis, Obesity

Brief summary

Multiple chronic conditions are common and expensive among patients aged ≥65 and are associated with lower quality of life, poorer response to treatment, worse medical and psychiatric outcomes, higher mortality, and higher costs of care. The primary purpose of this study is to conduct a randomized clinical trial (RCT) to examine the effects of ElderTree --a web-based intervention--on health outcomes and healthcare use among older adults with several chronic health conditions, such as diabetes, high blood pressure, high cholesterol, COPD, BMI over 30, congestive heart failure, chronic kidney disease, arrhythmia/atrial fibrillation, chronic pain, arthritis. The investigator's hypothesis is that patients assigned to TAU+ElderTree will have better quality of life and fewer primary care visits than those assigned to TAU+Internet.

Interventions

OTHERTreatment as usual (TAU) + Internet

Patients in this group will receive TAU+internet and links to helpful websites.

BEHAVIORALTAU + 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. are ≥65 years old 2. have been treated in the University of Wisconsin Health clinics for at least the previous 18 months with no plans to leave during the study period 3. have 3 or more of the following chronic conditions: hypertension, hyperlipidemia, diabetes, arthritis, BMI over 30, chronic kidney disease, congestive heart failure, arrhythmia/atrial fibrillation, pulmonary heart disease or pulmonary vascular disease, chronic pain, COPD 4. report no current psychotic disorder that would prevent participation 5. have no acute medical problem requiring immediate hospitalization 6. be able to read and sign the consent form in English 7. have no known terminal illness 8. be willing to share health-related study data and * Systolic and diastolic BP * Weight * BMI * HDL/LDL * HbA1C * pain score * lung function * health care utilization: number of ER visits, urgent care visits, primary care visits and specialty care visits 9. allow researchers to share information with their primary care physician

Design outcomes

Primary

Measure	Time frame	Description
PROMIS Global Health Measure Score	Measured at baseline and 12 months	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.
Psychological Flourishing Scale	Baseline and 12-months	Psychological 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.
UCLA Loneliness Scale	Baseline and 12-months	Loneliness 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.

Secondary

Measure	Time frame	Description
Medication Adherence	Baseline and 12-months	Medication 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.
Crisis Health Care Visits	Baseline and 12-months	Crisis 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.
Unhealthy Laboratory Scores	12-months	Laboratory 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.
Falls Requiring Medical Attention	Baseline and 12-months	Falls 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.
Long-term Care	Baseline and 12-months	Long-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.
Falls	Baseline and 12-months	Falls 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.
Symptom Distress	Baseline and 12-months	Symptom 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.

Countries

United States

Participant flow

Recruitment details

Recruitment was conducted from January 2018 to December 2019. The intervention period ended in June 2021.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	168
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.	176
Total	344

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	4	8
Overall Study	Lost to Follow-up	4	8

Baseline characteristics

Characteristic	Treatment as Usual (TAU) + ElderTree	Total	Treatment as Usual (TAU) + Internet
Age, Continuous	75.03 years STANDARD_DEVIATION 6.27	74.79 years STANDARD_DEVIATION 6.36	74.54 years STANDARD_DEVIATION 6.45
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	176 Participants	343 Participants	167 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Health Insurance type Affordable Care Act	0 Participants	0 Participants	0 Participants
Health Insurance type Covered under someone else	0 Participants	0 Participants	0 Participants
Health Insurance type Medicaid	1 Participants	3 Participants	2 Participants
Health Insurance type Medicare	69 Participants	126 Participants	57 Participants
Health Insurance type Military	0 Participants	0 Participants	0 Participants
Health Insurance type More than one source	103 Participants	208 Participants	105 Participants
Health Insurance type NA	1 Participants	2 Participants	1 Participants
Health Insurance type No insurance	0 Participants	0 Participants	0 Participants
Health Insurance type Private insurance	2 Participants	5 Participants	3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	8 Participants	22 Participants	14 Participants
Race (NIH/OMB) More than one race	4 Participants	5 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	164 Participants	317 Participants	153 Participants
Region of Enrollment United States	176 participants	344 participants	168 participants
Sex: Female, Male Female	106 Participants	209 Participants	103 Participants
Sex: Female, Male Male	70 Participants	135 Participants	65 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	4 / 168	8 / 176
other Total, other adverse events	0 / 168	0 / 176
serious Total, serious adverse events	0 / 168	0 / 176

Outcome results

Primary

PROMIS Global Health Measure Score

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.

Time frame: Measured at baseline and 12 months

Arm	Measure	Group	Value (MEAN)	Dispersion
Treatment as Usual (TAU) + Internet	PROMIS Global Health Measure Score	Baseline: Mental	46.27 T-score	Standard Deviation 7.42
Treatment as Usual (TAU) + Internet	PROMIS Global Health Measure Score	12 Months: Mental	44.92 T-score	Standard Deviation 6.82
Treatment as Usual (TAU) + Internet	PROMIS Global Health Measure Score	Baseline: Physical	42.40 T-score	Standard Deviation 6.5
Treatment as Usual (TAU) + Internet	PROMIS Global Health Measure Score	12 Months: Physical	42.13 T-score	Standard Deviation 6.3
Treatment as Usual (TAU) + ElderTree	PROMIS Global Health Measure Score	12 Months: Physical	42.41 T-score	Standard Deviation 6.32
Treatment as Usual (TAU) + ElderTree	PROMIS Global Health Measure Score	Baseline: Mental	46.21 T-score	Standard Deviation 7.16
Treatment as Usual (TAU) + ElderTree	PROMIS Global Health Measure Score	Baseline: Physical	42.35 T-score	Standard Deviation 5.99
Treatment as Usual (TAU) + ElderTree	PROMIS Global Health Measure Score	12 Months: Mental	46.38 T-score	Standard Deviation 7.34

Primary

Psychological Flourishing Scale

Psychological 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.