Multiple Chronic Conditions for Older Adults

NCT ID: NCT03387735

Last Updated: 2022-09-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-06-29

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Treatment as usual (TAU) + Internet

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

Group Type PLACEBO_COMPARATOR

Treatment as usual (TAU) + Internet

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

TAU + ElderTree

Intervention Type 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.

Interventions

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Treatment as usual (TAU) + Internet

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

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David H Gustafson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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UW Health Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39642938 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33605887 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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A195010

Identifier Type: OTHER

Identifier Source: secondary_id

ENGR\INDUSTRIAL ENGR\CHESS

Identifier Type: OTHER

Identifier Source: secondary_id

1R01HL134146-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-0849

Identifier Type: -

Identifier Source: org_study_id

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