NCT02833311

Brief Summary

Maintaining a healthy diet and engaging in routine physical activity may help decrease severity of symptoms, prevent secondary conditions, and slow functional decline in people with disabling neuromusculoskeletal conditions. However, people with these conditions face many health barriers to engaging in healthy behaviors. With the advent of portable technologies, such as smart phones, tablets and PDAs, there is a need to explore whether these technologies can help people with disabling conditions to stay motivated and overcome barriers to engaging in healthy behaviors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

May 12, 2023

Completed
Last Updated

May 12, 2023

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

July 12, 2016

Results QC Date

December 16, 2021

Last Update Submit

July 13, 2022

Conditions

Keywords

Neuromusculoskeletal condition

Outcome Measures

Primary Outcomes (1)

  • Changes From Baseline in Physical Activity

    Physical Activity and Disability Survey-Revised was administered to assess physical activity behavior. Scores can range from -2.7493 to 3.3671. Higher scores on the Physical Activity and Disability Survey-Revised indicates increased physical activity levels.

    Outcomes were administered immediately before the intervention and again 6-weeks later

Secondary Outcomes (4)

  • Changes From Baseline in Self-Report Physical Function

    Outcomes were administered immediately before the intervention and again 6-weeks later

  • Changes From Baseline in 6-minute Walking Test

    Outcomes were administered immediately before the intervention and again 6-weeks later

  • Changes From Baseline in Self-Efficacy

    Outcomes were administered immediately before the intervention and again 6-weeks later

  • Changes From Baseline in Weight

    Outcomes were administered immediately before the intervention and again 6-weeks later

Study Arms (3)

Computer Tablet Group

ACTIVE COMPARATOR

Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.

Behavioral: Computer Tablet Group

Paper and Pencil Group

ACTIVE COMPARATOR

Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.

Behavioral: Paper and Pencil Group

Contact Control Group

ACTIVE COMPARATOR

Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.

Behavioral: Contact Control Group

Interventions

A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.

Computer Tablet Group

Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.

Paper and Pencil Group

Participants are prescribed an exercise program and given information on healthy eating.

Contact Control Group

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician-confirmed diagnosis of a neuro-musculoskeletal condition or disease of the nerves, muscles, and/or bones that results in functional limitations
  • Physician consent to engage in home exercise/physical activity program
  • Regularly inactive (i.e., engaging in 90 minutes or less of purposeful physical activity each week)
  • Scoring ≤17 mental composite and ≤16 physical composite on the Global Health Questionnaire.
  • Have internet access (i.e., home, library or other WiFi location)

You may not qualify if:

  • If the only disabling condition reported is not considered a neuro-musculoskeletal disease
  • Have hand-motor function impairments that would limit use of the tablet
  • Often engage in healthy eating habits
  • Are frequent fallers (i.e., more than 3 falls per month)
  • Have a diagnoses of chronic obstructive pulmonary disease, serious mental health disorder, chronic heart failure, myocardial infarction, and other unstable/severe cardiovascular conditions, and uncontrolled diabetes mellitus (e.g., admission to the hospital within the past 6 months for uncontrolled diabetes)
  • Have severe cognitive deficits
  • Reports consistently tracking and monitoring health behaviors
  • Unable to effectively use the tablet technology during the pre-intervention usability demonstration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Plow M, Golding M. Using mHealth Technology in a Self-Management Intervention to Promote Physical Activity Among Adults With Chronic Disabling Conditions: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Dec 1;5(12):e185. doi: 10.2196/mhealth.6394.

MeSH Terms

Conditions

FibromyalgiaMultiple SclerosisOsteoarthritisSjogren's SyndromeParkinson Disease

Interventions

Paper

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesArthritisJoint DiseasesArthritis, RheumatoidXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Matthew Plow, Ph.D.
Organization
Case Western Reserve University

Study Officials

  • Matthew A Plow, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

November 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 12, 2023

Results First Posted

May 12, 2023

Record last verified: 2022-07

Locations