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NCT03387735

Multiple Chronic Conditions for Older Adults

Completed NA Results posted Last updated 1 September 2022
What this trial tests

NA trial testing Treatment as usual (TAU) + Internet in Chronic Disease in 346 participants. Completed in 29 June 2021.

Timeline
1 January 2018
Primary endpoint
29 June 2021
29 June 2021

Quick facts

Lead sponsorUniversity of Wisconsin, Madison
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment346
Start date1 January 2018
Primary completion29 June 2021
Estimated completion29 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Wisconsin, Madison

Who can join

65 and older, any sex, with Chronic Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PROMIS Global Health Measure Score Primary · 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.

Baseline: Mental
GroupValue95% CI
Treatment as Usual (TAU) + Internet46.27± 7.42
Treatment as Usual (TAU) + ElderTree46.21± 7.16
12 Months: Mental
GroupValue95% CI
Treatment as Usual (TAU) + Internet44.92± 6.82
Treatment as Usual (TAU) + ElderTree46.38± 7.34
Baseline: Physical
GroupValue95% CI
Treatment as Usual (TAU) + Internet42.40± 6.50
Treatment as Usual (TAU) + ElderTree42.35± 5.99
12 Months: Physical
GroupValue95% CI
Treatment as Usual (TAU) + Internet42.13± 6.30
Treatment as Usual (TAU) + ElderTree42.41± 6.32
Psychological Flourishing Scale Primary · 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.

Baseline
GroupValue95% CI
Treatment as Usual (TAU) + Internet31.55± 5.39
Treatment as Usual (TAU) + ElderTree31.12± 5.08
12-months
GroupValue95% CI
Treatment as Usual (TAU) + Internet31.50± 5.15
Treatment as Usual (TAU) + ElderTree31.48± 5.60
UCLA Loneliness Scale Primary · 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.

Baseline
GroupValue95% CI
Treatment as Usual (TAU) + Internet16.02± 5.77
Treatment as Usual (TAU) + ElderTree17.12± 6.04
12-months
GroupValue95% CI
Treatment as Usual (TAU) + Internet16.05± 6.27
Treatment as Usual (TAU) + ElderTree16.75± 5.86
Unhealthy Laboratory Scores Secondary · 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.

GroupValue95% CI
Treatment as Usual (TAU) + Internet0.64± 0.31
Treatment as Usual (TAU) + ElderTree0.64± 0.34
Falls Secondary · 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.

Baseline
GroupValue95% CI
Treatment as Usual (TAU) + Internet0.36± 0.95
Treatment as Usual (TAU) + ElderTree0.36± 0.88
12-months
GroupValue95% CI
Treatment as Usual (TAU) + Internet0.36± 0.89
Treatment as Usual (TAU) + ElderTree0.72± 4.09
Symptom Distress Secondary · 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.

Baseline
GroupValue95% CI
Treatment as Usual (TAU) + Internet21.10± 14.56
Treatment as Usual (TAU) + ElderTree20.58± 14.55
12-months
GroupValue95% CI
Treatment as Usual (TAU) + Internet18.86± 14.89
Treatment as Usual (TAU) + ElderTree18.58± 14.14
Medication Adherence Secondary · 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.

Baseline
GroupValue95% CI
Treatment as Usual (TAU) + Internet13.14± 4.36
Treatment as Usual (TAU) + ElderTree13.07± 3.88
12-months
GroupValue95% CI
Treatment as Usual (TAU) + Internet12.70± 4.23
Treatment as Usual (TAU) + ElderTree12.56± 4.07
Crisis Health Care Visits Secondary · 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.

Baseline
GroupValue95% CI
Treatment as Usual (TAU) + Internet0.42± 0.90
Treatment as Usual (TAU) + ElderTree0.45± 1.06
12-months
GroupValue95% CI
Treatment as Usual (TAU) + Internet0.86± 1.76
Treatment as Usual (TAU) + ElderTree0.76± 1.45
Long-term Care Secondary · 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.

Baseline
GroupValue95% CI
Treatment as Usual (TAU) + Internet0.01± 0.15
Treatment as Usual (TAU) + ElderTree0.25± 2.50
12-months
GroupValue95% CI
Treatment as Usual (TAU) + Internet0.79± 7.76
Treatment as Usual (TAU) + ElderTree0.29± 2.11
Falls Requiring Medical Attention Secondary · 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.

Baseline
GroupValue95% CI
Treatment as Usual (TAU) + Internet0.23± 0.50
Treatment as Usual (TAU) + ElderTree0.18± 0.39
12-months
GroupValue95% CI
Treatment as Usual (TAU) + Internet0.33± 0.84
Treatment as Usual (TAU) + ElderTree0.16± 0.37

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Self-management interventions for people with chronic obstructive pulmonary disease.
    Schrijver J, Lenferink A, Brusse-Keizer M, Zwerink M, et al · · 2022 · cited 105× · PMID 35001366 · DOI 10.1002/14651858.cd002990.pub4
  2. Digital interventions for the management of chronic obstructive pulmonary disease.
    Janjua S, Banchoff E, Threapleton CJ, Prigmore S, et al · · 2021 · cited 55× · PMID 33871065 · DOI 10.1002/14651858.cd013246.pub2
  3. Tailored or adapted interventions for adults with chronic obstructive pulmonary disease and at least one other long-term condition: a mixed methods review.
    Dennett EJ, Janjua S, Stovold E, Harrison SL, et al · · 2021 · cited 23× · PMID 34309831 · DOI 10.1002/14651858.cd013384.pub2
  4. A Web-Based eHealth Intervention to Improve the Quality of Life of Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial.
    Gustafson DH, Mares ML, Johnston DC, Mahoney JE, et al · · 2021 · cited 12× · PMID 33605887 · DOI 10.2196/25175
  5. An eHealth Intervention to Improve Quality of Life, Socioemotional, and Health-Related Measures Among Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial.
    Gustafson DH, Mares ML, Johnston D, Vjorn OJ, et al · · 2024 · cited 2× · PMID 39642938 · DOI 10.2196/59588

Verify or expand the search:

Other recruiting trials for Chronic Disease

Currently open trials in the same condition.

Other University of Wisconsin, Madison trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03387735.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing