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Multiple Chronic Conditions for Older Adults

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment as usual (TAU) + Internet
TAU + ElderTree
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Disease focused on measuring Hypertension, Hyperlipidemia, Diabetes, Arthritis, Obesity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UW Health Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Treatment as usual (TAU) + Internet

Treatment as usual (TAU) + ElderTree

Arm Description

Patients will be given access to helpful websites such as National Institute on Aging.

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.

Outcomes

Primary Outcome Measures

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.
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.
UCLA Loneliness Scale
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 Outcome Measures

Unhealthy Laboratory Scores
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
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
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.
Medication Adherence
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
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.
Long-term Care
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 Requiring Medical Attention
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.

Full Information

First Posted
November 2, 2017
Last Updated
August 10, 2022
Sponsor
University of Wisconsin, Madison
Collaborators
Medical University of South Carolina, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03387735
Brief Title
Multiple Chronic Conditions for Older Adults
Official Title
Heart-Related Multiple Chronic Conditions in Primary Care: Behavioral Technology
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Medical University of South Carolina, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Hypertension, Hyperlipidemia, Diabetes, Arthritis, Obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
346 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual (TAU) + Internet
Arm Type
Placebo Comparator
Arm Description
Patients will be given access to helpful websites such as National Institute on Aging.
Arm Title
Treatment as usual (TAU) + ElderTree
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU) + Internet
Intervention Description
Patients in this group will receive TAU+internet and links to helpful websites.
Intervention Type
Behavioral
Intervention Name(s)
TAU + ElderTree
Intervention Description
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.
Primary Outcome Measure Information:
Title
PROMIS Global Health Measure Score
Description
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
Title
Psychological Flourishing Scale
Description
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.
Time Frame
Baseline and 12-months
Title
UCLA Loneliness Scale
Description
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.
Time Frame
Baseline and 12-months
Secondary Outcome Measure Information:
Title
Unhealthy Laboratory Scores
Description
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.
Time Frame
12-months
Title
Falls
Description
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.
Time Frame
Baseline and 12-months
Title
Symptom Distress
Description
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.
Time Frame
Baseline and 12-months
Title
Medication Adherence
Description
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.
Time Frame
Baseline and 12-months
Title
Crisis Health Care Visits
Description
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.
Time Frame
Baseline and 12-months
Title
Long-term Care
Description
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.
Time Frame
Baseline and 12-months
Title
Falls Requiring Medical Attention
Description
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.
Time Frame
Baseline and 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: are ≥65 years old 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 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 report no current psychotic disorder that would prevent participation have no acute medical problem requiring immediate hospitalization be able to read and sign the consent form in English have no known terminal illness 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 allow researchers to share information with their primary care physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Gustafson, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Health Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33605887
Citation
Gustafson DH Sr, Mares ML, Johnston DC, Mahoney JE, Brown RT, Landucci G, Pe-Romashko K, Cody OJ, Gustafson DH Jr, Shah DV. A Web-Based eHealth Intervention to Improve the Quality of Life of Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 19;10(2):e25175. doi: 10.2196/25175.
Results Reference
derived

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Multiple Chronic Conditions for Older Adults

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