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Trial record 1 of 1 for:    NCT03023813
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Individualizing Disease Prevention for Middle-Aged 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: NCT03023813
Recruitment Status : Terminated (Study was terminated on 2/17/2021 due to on-going and uncertain nature of COVID-19 pandemic; this was not a suspension of IRB approval.)
First Posted : January 18, 2017
Results First Posted : June 29, 2021
Last Update Posted : April 26, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Glen Taksler, The Cleveland Clinic

Study Description
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Brief Summary:
The primary objective of this study is to help patients compare the benefits of various preventive care services, based on their individual risk factors (such as smoking status, obesity, high blood pressure, high cholesterol, etc.). A tailored decision tool will be provided to each participant during primary care appointments to facilitate discussion between the participant and his/her provider regarding prioritizing preventive service recommendations.

Condition or disease Intervention/treatment Phase
Primary Health Care Other: Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multiple round pilot testing. Some round(s) will have a single group with 1 arm. Other round(s) will be parallel with 2 arms.
Masking: None (Open Label)
Masking Description: Only the 2 arm round(s) will be randomized.
Primary Purpose: Prevention
Official Title: Individualizing Disease Prevention for Middle-Aged Adults
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : March 12, 2020
Actual Study Completion Date : March 12, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Individualized preventive care recommendations will be distributed to subjects.
 Other: Intervention
Written material provided.
No Intervention: Control
Usual care
Experimental: Development Phase
Non-randomized receipt of individualized preventive care recommendations
 Other: Intervention
Written material provided.


Outcome Measures
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Primary Outcome Measures :
  1. Interest in Individualized Preventive Care Recommendations. [ Time Frame: Within 3 days of index primary care appointment. ]

    Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.

    Survey question: "Overall, how helpful did you find the written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome)


  2. Interest in Individualized Preventive Care Recommendations. [ Time Frame: Within 3 days of index primary care appointment. ]

    Measured by individualized preventive service recommendations, tailored to patient's specific medical conditions. Measured by surveys.

    Survey question: "In the future, would you like to see updated written materials (handouts)?" Ten point scale (minimum 1, maximum 10, higher score is better outcome)



Secondary Outcome Measures :
  1. Use of Shared Decision Making. [ Time Frame: Within 3 days of index primary care appointment. ]
    Measured by surveys. Survey metric: Shared Decision Making (SDM)-Q-9 validated scale, converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)

  2. Patient Readiness to Change Health Behaviors. [ Time Frame: Within 3 days of index primary care appointment. ]
    Measured by surveys. Proportion of top-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower

  3. Patient Readiness to Change Health Behaviors [ Time Frame: Within 3 days of index primary care appointment ]
    Measured by surveys Proportion of top-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of top-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower

  4. Patient Readiness to Change Health Behaviors. [ Time Frame: Within 3 days of index primary care appointment ]
    Measured by surveys Proportion of bottom-3 individualized preventive service recommendations ready to change over next 1 month Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 1 month (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower

  5. Patient Readiness to Change Health Behaviors [ Time Frame: Within 3 days of index primary care appointment ]
    Measured by surveys. Proportion of bottom-3 individualized preventive service recommendations ready to change over next 2-6 months Numerator: Number of bottom-3-ranked recommendations with score >=6 out of 7 on Likert scale for readiness to change over next 2-6 months (minimum=1, maximum=7, higher score was better) Denominator: The number of individualized preventive service recommendations provided to a patient or 3, whichever was lower

  6. Decisional Comfort. [ Time Frame: Within 3 days of index primary care appointment. ]
    Measured by surveys. Survey metric: Decisional Conflict Scale (validated scale), converted to 100 point denominator 100 point scale (minimum 1, maximum 100, higher score is better outcome)

  7. Preventive Care Outcomes for Patients. [ Time Frame: Within 1 year of index primary care appointment. ]
    Number of participants with at least 1 follow-up encounter during the 1 year after an index encounter.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Scheduled for an appointment with primary care provider during study period
  • Two or more of the following risk factors:
  • Tobacco use
  • Overweight/obese
  • Hypertension
  • Hyperlipidemia
  • Diabetes
  • Alcohol Misuse
  • Depression
  • History of Sexually Transmitted Infection
  • Being overdue for the following screenings: Colorectal, cervical, breast, lung

Exclusion Criteria:

- Severely limited life expectancy (cancer, congestive heart failure, chronic obstructive pulmonary disease, end stage renal disease)

Contacts and Locations
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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): NCT03023813


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Glen Taksler
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Glen Taksler, PhD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Glen Taksler, The Cleveland Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] March 8, 2018
Informed Consent Form  [PDF] September 11, 2019

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Glen Taksler, Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03023813    
Other Study ID Numbers: 16-854
First Posted: January 18, 2017    Key Record Dates
Results First Posted: June 29, 2021
Last Update Posted: April 26, 2022
Last Verified: March 2022
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