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Completed

NCT Number: NCT04893590

Adapting MHealth Technology to Improve Patient Activation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline and up to 2 weeks post intervention

    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.

Secondary outcomes

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

    Time frame: Baseline and up to 2 weeks post intervention

    The Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue and the impact of fatigue. The fatigue short forms are not disease specific and assess fatigue over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "not at all (1)" to "very much (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score.

    The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

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

    Time frame: Baseline and up to 2 weeks post intervention

    The Sleep disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The sleep disturbance short forms are not disease specific and assess sleep disturbances over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "very poor (1)" to "very good (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score.

    The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Foundation for Barnes-Jewish Hospital

Registry information

Official study title

Adapting MHealth Technology to Improve Patient Activation and Overall Wellness for Persons with Disabilities

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 19, 2021
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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