Spinal Cord InjuriesNCT04893590
Adapting MHealth Technology to Improve Patient Activation
A study testing Fatigue self-management SMS intervention in people with Spinal Cord Injuries and Stroke, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Stroke, Multiple Sclerosis
- What is being tested?
- Fatigue self-management SMS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- evidence of acute condition (e.g. relapse)
- sleep apnea
- inability to answer interview questions or provide consent
- terminal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: Adapting MHealth Technology to Improve Patient Activation and Overall Wellness for Persons with Disabilities
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Stroke, Multiple Sclerosis
- Being tested
- Fatigue self-management SMS intervention
- Keywords
- Fatigue, Persons with disabilities, Patient activation, Mobile health
- Medical subject headings
- Spinal Cord Injuries, Stroke, Multiple Sclerosis, Fatigue, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue self-management SMS interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Fatigue self-management SMS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 2 weeks post intervention
Secondary outcomes (2)
The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Short Form 8a
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.
Measured: Baseline and up to 2 weeks post intervention
The Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Short Form 8a
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.
Measured: Baseline and up to 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start14 May 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Responsible party
- Principal investigator, Kerri Morgan, Washington University School of Medicine
- Investigators
- Kerri Morgan, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893590
- Sponsor's protocol ID
- 202103191
- Status last verified
- Mar 2025
- First submitted
- 14 May 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting MHealth Technology to Improve Patient Activation and Overall Wellness for Persons with Disabilities
- ClinicalTrials.gov ID
- NCT04893590
- Acronym / sponsor ID
- 202103191
- Conditions
- Spinal Cord Injuries, Stroke, Multiple Sclerosis
- Keywords
- Fatigue, Persons with disabilities, Patient activation, Mobile health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Foundation for Barnes-Jewish Hospital
- Study start
- 14 May 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fatigue self-management SMS intervention | Experimental | Behavioral: Fatigue self-management SMS interventionThe participants will receive a 12-week fatigue self-management SMS text intervention using mobile phones to target patient activation levels in people with disabilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- evidence of acute condition (e.g. relapse)
- sleep apnea
- inability to answer interview questions or provide consent
- terminal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigue self-management SMS interventionParticipants 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. | Behavioural | Fatigue self-management SMS intervention |
Primary outcome
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.
2 secondary outcomes
The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Short Form 8a
Time frame: Baseline and up to 2 weeks post intervention
The Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Short Form 8a
Time frame: Baseline and up to 2 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Morgan, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue self-management SMS intervention in people with Spinal Cord Injuries and Stroke, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation - change in knowledge, skill and confidence for self-management (time frame: Baseline and up to 2 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.