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Multiple Chronic Conditions for Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03387735
Recruitment Status : Active, not recruiting
First Posted : January 2, 2018
Last Update Posted : January 21, 2020
Sponsor:
Collaborators:
University of Wisconsin Hospital and Clinics (UW Health)
Medical University of South Carolina
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
Chronic Disease Other: Treatment as usual (TAU) + Internet Behavioral: TAU + ElderTree Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Heart-Related Multiple Chronic Conditions in Primary Care: Behavioral Technology
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Placebo Comparator: Treatment as usual (TAU) + Internet
Patients will be given access to helpful websites such as National Institute on Aging.
Other: Treatment as usual (TAU) + Internet
Patients in this group will receive TAU+internet and links to helpful websites.

Experimental: 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.
Behavioral: 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.





Primary Outcome Measures :
  1. Health outcomes [ Time Frame: up to 18 months ]
    The investigator's hypothesis is that participants assigned to TAU+ElderTree will have better quality of life than those assigned to TAU+Internet. The investigators will be measuring the quality of life using PROMIS Global Health (10) SF to see if there are any changes to the quality of life reported in the baseline survey, 6, 12, 18 month follow-up surveys.

  2. Healthcare use [ Time Frame: up to 18 months ]
    The investigator's hypothesis is that participants assigned to TAU+ElderTree will have less primary care use (fewer visits) than those assigned to TAU+Internet. The investigators will be measuring the use of health services to see if there are any changes to their visits to primary care clinic, emergency room, urgent care clinic and specialty care visits as reported in the baseline survey, 6, 12, 18 month follow-up surveys.


Secondary Outcome Measures :
  1. Chronic condition outcome: Hypertension [ Time Frame: 18 months ]
    The investigator's hypothesis is that participants assigned to TAU+ElderTree will have improved individual condition outcomes such as hypertension than participants assigned to TAU+Internet. The investigators will look at the hypertension level using a data pull from the participants' medical records to see if there are any changes in their millimeters of mercury (mm Hg).

  2. Chronic condition outcome: Hyperlipidemia [ Time Frame: 18 months ]
    The investigator's hypothesis is that participants assigned to TAU+ElderTree will have improved individual condition outcomes such as hyperlipidemia (LDL) than participants assigned to TAU+Internet. The investigators will be looking at the LDL level using a data pull from the participants' medical records to see if there are any changes in their LDL (bad cholesterol) in their blood.

  3. Chronic condition outcome: HbA1c for diabetes [ Time Frame: 18 months ]
    The investigator's hypothesis is that participants assigned to TAU+ElderTree will have improved individual condition outcomes such as HbA1c than participants assigned to TAU+Internet. The investigators will be looking at the HbA1c level using a data pull from the participants' medical records to see if there are any changes in their HbA1c level.

  4. Chronic condition outcome: Pain [ Time Frame: 18 months ]
    The investigator's hypothesis is that participants assigned to TAU+ElderTree will have improved individual condition outcomes such as arthritis pain than participants assigned to TAU+Internet. The investigators will be looking at the pain score using a data pull from the participants' medical records to see if there are any changes in their pain level.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387735


Locations
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United States, Wisconsin
UW Health Clinics
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
University of Wisconsin, Madison
University of Wisconsin Hospital and Clinics (UW Health)
Medical University of South Carolina
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: David H Gustafson, PhD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03387735    
Other Study ID Numbers: 2017-0849
A195010 ( Other Identifier: UW Madison )
ENGR\INDUSTRIAL ENGR\CHESS ( Other Identifier: UW Madison )
1R01HL134146-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Hypertension, Hyperlipidemia, Diabetes, Arthritis, Obesity
Additional relevant MeSH terms:
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Chronic Disease
Multiple Chronic Conditions
Disease Attributes
Pathologic Processes