Care Coordination Approaches to Learning Lupus Self-management

NCT04400240 | Completed DMC

• 1 other identifier: 00070647
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The Care-coordination Approach to Learning Lupus Self-Management (CALLS) study was designed to examine whether modeling and reinforcement from a lay patient navigator/care coordinator improves disease self-management, indicators of disease activity, health related quality of life (HRQOL), and 30-day readmission in SLE inpatient admissions. We recruited 30 patients (\~15 questionnaires and phone sessions and 15 questionnaires only) with active SLE upon hospital admittance at the Medical University of South Carolina (MUSC). The lay patient navigator/care coordinator was trained to deliver intervention content by twelve weekly telephone sessions carried out across the course of the study. All participants were assessed using validated measures of patient reported outcomes at baseline, mid-intervention (6 weeks post-enrollment), and immediately following the intervention (12 weeks post-enrollment). Outcomes for patients who agreed to phone sessions were compared with the outcomes of patients who opted to participate in questionnaires only. The study lasted 12 months, with recruitment and enrollment over 6 months, 3 months for intervention delivery and 3 months for data analysis.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Change in Self-management measured using the Patient Activation Measure (PAM)

  The Patient Activation Measure (PAM) assesses an individual's knowledge, skill, and confidence for managing their health and healthcare. Individuals who measure high on this assessment typically understand the importance of taking a proactive role in managing their health and have the skills and confidence to do so. The PAM survey measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum, including "Believes Active Role Important", "Confidence and Knowledge to Take Action", "Taking Action", and "Staying Course Under Stress". Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes.

  Baseline to post-intervention, at 12 weeks

• Satisfaction in Quality of Life as assessed by the LUP-QOL (Lupus Quality of Life Questionnaire)

  Quality of life will be assessed by using The LUP-QOL (Lupus Quality of Life Questionnaire), which assesses areas of the participant's life that may be affected by lupus. The score ranges from 0-100. A score of '0' indicates the lowest quality of life, and a score of 100 indicates the best quality of life.

  Baseline to post-intervention, at 12 weeks

Secondary Outcomes (1)

• 30-day readmission

  Baseline to post-intervention, at 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

complete questionnaires and phone sessions

Behavioral: CALLS

Control

NO INTERVENTION

complete questionnaires only

Interventions

CALLS BEHAVIORAL

The CALLS program will consist of 12 weeks of service delivery that will include one standard educational session by telephone or in-person meeting every week. The weekly educational session will be generally structured in three parts: introduction, structured education, and problem solving. Weekly content will be adapted from the twelve modules of the Peer Approaches to Lupus Self-management (PALS) study, and further tailored according to prominent barriers to care in the scientific literature. Content will include: 1) Medication adherence; 2) Communication with provider; 3) Patient engagement; 4) Recognizing and treating depression; 5) Overcoming socioeconomic barriers; 6) Social Support network; 7) Appointment/ Lab adherence; and 8) Transportation.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospital admission for SLE-related issue;
• clinical diagnosis of systemic lupus erythematosus (SLE) from a physician;
• years of age or older;
• able to provide informed consent and take part in ongoing assessment/evaluation activities (self-reported questionnaires);
• able to commit to duration of study (3 months);
• able to communicate in English; and
• have an active phone line (landline or cell phone) for the duration of the study, if agreeing to phone sessions with the lay patient navigator/care coordinator.

You may not qualify if:

• cognitive impairment;
• acute decompensation of chronic conditions precluding participation;
• conditions that preclude participation in assessments (e.g. blindness or deafness); and
• terminal illness or life expectancy less than 6 months as evaluated by physician.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• White AA, Ba A, Faith TD, Ramakrishnan V, Dismuke-Greer CL, Oates JC, Williams EM. The Care-coordination Approach to Learning Lupus Self-Management: a patient navigator intervention for systemic lupus inpatients. Lupus Sci Med. 2021 May;8(1):e000482. doi: 10.1136/lupus-2021-000482.

  PMID: 33975925 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 22, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)