Multiple Chronic Conditions for Older Adults

NCT03387735 | Completed Results DMC

• 4 other identifiers: 2017-0849A195010ENGR\INDUSTRIAL ENGR\CHESS1R01HL134146-01A1
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Keywords

Hypertension, Hyperlipidemia, Diabetes, Arthritis, Obesity

Outcome Measures

Primary Outcomes (3)

• 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.

  Measured at baseline and 12 months

• 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.

  Baseline and 12-months

• 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.

  Baseline and 12-months

Secondary Outcomes (7)

• Unhealthy Laboratory Scores

  12-months

• Falls

  Baseline and 12-months

• Symptom Distress

  Baseline and 12-months

• Medication Adherence

  Baseline and 12-months

• Crisis Health Care Visits

  Baseline and 12-months

Study Arms (2)

Treatment as usual (TAU) + Internet

PLACEBO COMPARATOR

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

Other: Treatment as usual (TAU) + Internet

Treatment as usual (TAU) + ElderTree

EXPERIMENTAL

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

Interventions

Treatment as usual (TAU) + Internet OTHER

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

Treatment as usual (TAU) + Internet

TAU + ElderTree BEHAVIORAL

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.

Treatment as usual (TAU) + ElderTree

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Medical University of South Carolina: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UW Health Clinics

Madison, Wisconsin, 53704, United States

Location

Related Publications (2)

• Gustafson DH Sr, Mares ML, Johnston D, Vjorn OJ, Curtin JJ, Landucci G, Pe-Romashko K, Gustafson DH Jr, Shah DV. An eHealth Intervention to Improve Quality of Life, Socioemotional, and Health-Related Measures Among Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial. JMIR Aging. 2024 Dec 6;7:e59588. doi: 10.2196/59588.

  PMID: 39642938 DERIVED

• 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.

  PMID: 33605887 DERIVED

MeSH Terms

Conditions

Chronic Disease; Hypertension; Hyperlipidemias; Diabetes Mellitus; Arthritis; Obesity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Joint Diseases; Musculoskeletal Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Limitations and Caveats

We did not have health lab score baseline data for all participants

Results Point of Contact

• Title: CHESS Statistician
• Organization: UW Madison

ocody@wisc.edu

6084772614

Study Officials

• David H Gustafson, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: January 2, 2018
• Study Start: January 1, 2018
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: September 1, 2022
• Results First Posted: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)