Multiple Chronic Conditions for Older Adults

Chronic Disease Clinical Trial

Official title:

Heart-Related Multiple Chronic Conditions in Primary Care: Behavioral Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387735
• Other study ID #: 2017-0849
• Secondary ID: A195010ENGR\INDU
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 29, 2021

Study information

• Verified date: August 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Multiple Chronic Conditions

Intervention

Other:
• Treatment as usual (TAU) + Internet
Patients in this group will receive TAU+internet and links to helpful websites.

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.

Locations

Country	Name	City	State
United States	UW Health Clinics	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Medical University of South Carolina, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	12-months
Secondary	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.	Baseline and 12-months
Secondary	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.	Baseline and 12-months
Secondary	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.	Baseline and 12-months
Secondary	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.	Baseline and 12-months
Secondary	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.	Baseline and 12-months
Secondary	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.	Baseline and 12-months