Implementing the Decision-Aid for Lupus (IDEAL Strategy) (IDEAL)
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ClinicalTrials.gov Identifier: NCT03735238 |
Recruitment Status :
Recruiting
First Posted : November 8, 2018
Last Update Posted : July 10, 2020
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Condition or disease | Intervention/treatment |
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Systemic Lupus Erythematosus | Other: SMILE Computerized Decision-Aid |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Case-Only |
Time Perspective: | Other |
Official Title: | Implementing the Decision-Aid for Lupus (IDEAL Strategy) |
Actual Study Start Date : | December 15, 2018 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 15, 2021 |

Group/Cohort | Intervention/treatment |
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Lupus Patients
All lupus patients, regardless of if they are having an active flare
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Other: SMILE Computerized Decision-Aid
SMILE is a computerized decision-aid designed to give lupus patients information about lupus, treatments for lupus available to them, as well as side effects. This will be administered at every lupus clinic session. Every patient will see the SMILE Computerized Decision-Aid at their index baseline clinic visit.
Other Names:
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- Penetration [ Time Frame: 24 months ]This is measured using study records (# of patients viewed the Decision Aid (DA)/ # of eligible patients)
- Perceived Acceptability of Intervention Measure (IAM) for Decision Aid (DA) [ Time Frame: 12 months ]Clinic personnel's perception of the acceptability of the decision-aid, measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater acceptability (i.e., better outcome).
- Perceived DA Implementation Success [ Time Frame: 12 months ]Clinic personnel's perception of the implementation success of the decision-aid, measured using a validated scale with three (3) items with responses ranging from 1 ("Disagree") to 5 ("Agree"). These three items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater implementation success (i.e., better outcome).
- Perceived DA Permanence [ Time Frame: 12 months ]Clinic personnel's perception of the permanence of the decision-aid, measured using one validated item that is scored ranging from 1 ("Not at all permanent") to 5 ("Extremely permanent"). This item will be examined by itself, where higher scores indicate perceptions of greater permanence of the decision-aid in the clinic (i.e., better outcome).
- Patient perception of DA Usefulness [ Time Frame: 0 months ]Patient perception of the effect of the decision-aid on preparing the patient for decision making measured using the Preparation for Decision Making (PDM), a validated scale consisting of 10 questions scored on an ordinal scale from (not at all =1) to (a great deal = 5). For scoring, sum the score of the 10 items and divide by 10. Scores can then be converted to a 0-100 scale by subtracting 1 from this summed score and multiplying by 25.
- Patient Satisfaction for Decision Aid (DA) [ Time Frame: 0 months ]Patient satisfaction with the ease of the use of the decision-aid measured using a validated single item scale scored on an ordinal scale from (strongly disagree =1) to (strongly agree = 5). This item will be examined by itself, where higher scores indicate greater patient satisfaction with the decision aid (i.e., better outcome). This is a single item scale, and there are no subscales. It was adapted from another study that assessed satisfaction with IPad or interactive voice response.
- Perceived Intervention Appropriateness Measure (IAM) for Decision Aid (DA) [ Time Frame: 12 Months ]Clinic personnel's perception of the appropriateness of the decision-aid, measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater appropriateness (i.e., better outcome).
- Perceived Feasibility of Intervention Measure (FIM) for Decision Aid (DA) [ Time Frame: 12 Months ]Clinic personnel's perception of the feasibility of the decision-aid, measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater feasibility (i.e., better outcome).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Clinic Personnel Inclusion Criteria:
- Aim 1: clinic personnel involved in the care of lupus patients
- Aim 2: clinic personnel involved in the care of lupus patients
- Aim 3: clinic personnel involved in the care of lupus patients
Clinic Personnel Exclusion Criteria:
- Aim 1: none
- Aim 2: none
- Aim 3: none
Patient Inclusion Criteria:
- Aim 2: Adults with a diagnosis of lupus
- Aim 3: Adults with a diagnosis of lupus
Patient Exclusion Criteria:
- Aim 2: No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status
- Aim 3: No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status

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): NCT03735238
Contact: Candace Green, BA | 205-975-2405 | candacegreen@uabmc.edu | |
Contact: Deztanity Tatum, BS | 205-934-0315 | dtatum@uabmc.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Candace Green, BA 205-975-2405 candacegreen@uabmc.edu | |
Contact: Deztanity Tatum, BS 205-934-0315 dtatum@uabmc.edu | |
Principal Investigator: Jasvinder Singh, MD, MPH |
Principal Investigator: | Jasvinder A Singh, MD, MPH | University of Alabama at Birmingham |
Responsible Party: | Jasvinder Singh, MD, MPH, Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT03735238 |
Other Study ID Numbers: |
300002272 |
First Posted: | November 8, 2018 Key Record Dates |
Last Update Posted: | July 10, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
lupus decision making implementation |
SLE decision-aid decision conflict |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |