Clinical trial NCT04893590: Adapting MHealth Technology to Improve Patient Activation
Official title: Adapting MHealth Technology to Improve Patient Activation and Overall Wellness for Persons with Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Stroke
Multiple Sclerosis
Keywords: Fatigue
Persons with disabilities
Patient activation
Mobile health
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
First posted: 2021-05-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Persons with disabilities (PwD) commonly experience fatigue, which adversely impacts their everyday lives. Information to manage and improve fatigue can be complicated and overwhelming. Little has been done to link mobile health (mHealth) approaches with patient activation and self-management to effectively address fatigue for PwD. The purpose of this study is to develop and pilot-test a fatigue self-management short message service (SMS) text intervention using mobile phones to target patient activation levels in PwD. The proposed study will: (1) develop content for a fatigue self-management intervention using SMS tailored to patient activation levels in persons with multiple sclerosis, spinal cord injury, and stroke. An advisory board made up of one physical medicine and rehabilitation physician and six PwD will provide input on the content and format for the developed content. (2) test the feasibility and acceptability of SMS to improve patient activation for fatigue self-management in PwD. The long-term goal is to improve the health of PwD by increasing their skills, confidence, and knowledge to manage fatigue and other chronic symptoms that affect their daily life.

Eligibility criteria: Inclusion Criteria:

* 18 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

Exclusion Criteria:

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

Primary outcomes:
measure: Patient Activation - change in knowledge, skill and confidence for self-management
timeFrame: Baseline and up to 2 weeks post intervention
Secondary outcomes:
measure: The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Short Form 8a
timeFrame: Baseline and up to 2 weeks post intervention
measure: The Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Short Form 8a
timeFrame: Baseline and up to 2 weeks post intervention
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kerri Morgan, PhD
role: PRINCIPAL_INVESTIGATOR
References: