Adapting MHealth Technology to Improve Patient Activation

NCT04893590 | Completed

• 1 other identifier: 202103191
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Persons with disabilities (PwD) commonly experience fatigue, which often negatively impacts their everyday lives. Management of this symptom can be challenging. Satisfaction with current interventions to manage fatigue is low among PwD and there is a desire for more personalized approaches. The purpose of this study is to develop and test a fatigue self-management intervention using mobile phones that is personalized to each person's needs.

Conditions

Spinal Cord Injuries; Stroke; Multiple Sclerosis

Keywords

Fatigue; Persons with disabilities; Patient activation; Mobile health

Outcome Measures

Primary Outcomes (1)

• Patient Activation - change in knowledge, skill and confidence for self-management

  The Patient Activation Measure (PAM-13) assesses four levels of activation: (1) the patient is disengaged and overwhelmed, (2) the patient is becoming aware but still struggling, (3) the patient takes action, and (4) the patient maintains behaviors. The psychometric properties of the PAM have been assessed in multiple healthcare settings. Raw PAM scores can be transformed into a continuous (0-100) scale, where higher scores represent higher levels of patient activation. In order to target self-management strategies, participants will proceed through these levels.

  Baseline and up to 2 weeks post intervention

Secondary Outcomes (2)

• The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Short Form 8a

  Baseline and up to 2 weeks post intervention

• The Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Short Form 8a

  Baseline and up to 2 weeks post intervention

Study Arms (1)

Fatigue self-management SMS intervention

EXPERIMENTAL

The participants will receive a 12-week fatigue self-management SMS text intervention using mobile phones to target patient activation levels in people with disabilities.

Behavioral: Fatigue self-management SMS intervention

Interventions

Fatigue self-management SMS intervention BEHAVIORAL

Participants will set up an initial goal for the SMS intervention related to fatigue management, and prior to beginning the intervention they will be trained to use the SMS system. Participants will receive text messages each day, providing tips and techniques to help self-manage fatigue. Weekly the participants will be asked to provide feedback regarding their fatigue levels and their patient activation will be re-assessed at the halfway point of intervention.

Fatigue self-management SMS intervention

Eligibility Criteria

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

You may qualify if:

• years of age or older
• had disability for at least one year
• score of less than 10 on the Modified Fatigue Impact Scale 5 question (MFIS-5)
• ability to read and speak English at the 6th grade level
• willing to use their own phone and SMS

You may not qualify if:

• evidence of acute condition (e.g. relapse)
• sleep apnea
• inability to answer interview questions or provide consent
• terminal cancer

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke; Multiple Sclerosis; Fatigue; Patient Participation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kerri Morgan, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Occupation Therapy and Neurology

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: May 14, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

US (1)