Improving Self-Management Skills Among People With Spinal Cord Injury

NCT03140501 | Unknown

• 1 other identifier: 440872
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of our study is to evaluate the use of a self-management application ("app") that the investigators have developed to help facilitate self-management among individuals with SCI who live in the community. The main purpose is to create and fulfill individual self-management goals. Other purposes include improving self-management and health conditions related to SCI. During the initial phase, participants (SCI clinicians and patients with SCI) reported positive usage of the self-management app and all agreed it would benefit people with SCI. With the widespread use of portable electronic devices, an opportunity exists to help patients and informal caregivers on the journey from rehabilitation to integration back into the community. The investigators will use a randomized controlled trial (randomly putting participants into two groups), including both surveys and interviews. The study will involve the use of the app that focuses on the self-management of SCI, along with five to six in-person or telephone meetings over a three-month period. Our proposal is original in that it will be one of the few randomized control trials for e-health interventions for self-care management for those with SCI. The overall goals of the study is to develop an affordable self-management app that can be used to encourage self-management in people living with SCI. This app would be used along with other health problem specific apps that are more detailed and expensive, while helping participants to manage their long-term health problems related to their SCI in an easily usable and affordable form.

Conditions

Spinal Cord Injuries; Self-Management; Mobile Application

Outcome Measures

Primary Outcomes (1)

• Goal Attainment Scaling (GAS)

  GAS is a promising approach for evaluating psychosocial interventions in community settings. This measure will be used to identify self-management goals that participants want to achieve. Objective outcomes are identified that indicate degrees of attainment of participant-selected goals on a five-point scale ranging from -2 to +2, where -2 is a much worse than expected outcome, 0 represents attaining the goal (the anticipated outcome) and 2 means a much better than expected outcome, and then aggregate T-scores are calculated. The minimally clinically important change for GAS is 10, based on the linear T-score, which represents a change in score from the anticipated values.

  At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline

Secondary Outcomes (10)

• Self-Efficacy for Managing Chronic Disease Scale

  At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline

• Spinal Cord Injury Secondary Conditions Scale

  At 0 months (baseline), 3 months after baseline, 6 months after baseline, and 9 months after baseline

• Self-Reported Healthcare Utilization

  Throughout the study, up until the end-point (9 months)

• Spinal Cord Independence Measure III

  At 0 months (baseline)

• American Spinal Injury Association Impairment Scale

  At 0 months (baseline)

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Participants randomized to this group will receive the intervention, the mobile application ("app"), immediately after baseline data are collected.

Device: Mobile application ("app")

Delayed intervention

OTHER

Participants randomized to this group will receive the intervention, the mobile application ("app"), after a three month delay.

Device: Mobile application ("app")

Interventions

Mobile application ("app") DEVICE

The self-management app has 3 main features: 1) SCI-specific education modules; 2) a "circle-of-care" in which the users select health allies (formal and informal caregivers); and 3) a variety of tools to assist with goal identification, symptom/behaviour tracking, etc. The intervention will involve 5-6 contacts that occur over a 3-month period and ongoing use of the app. There will be 1 to 2 in-person sessions, where the principles of self-management are reviewed, self-management goals are identified, and features of the app are explained. Over the next month, there will be 2 follow-up contacts to review any questions/issues participants have. Participants can set additional goals during this time. Over the last 2 months, there will be monthly contacts to address the same issues.

Delayed intervention; Immediate Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have been discharged from inpatient rehabilitation following a spinal cord injury at least one year prior
• Are living in the community setting
• Are 19 years of age or over
• Speak, read, and write English
• Have reliable access to internet
• Are capable of providing your own informed consent

You may not qualify if:

• Are unable to provide informed consent (due to severe mental illness or traumatic brain injury)
• Have previously used a self-management mobile app focused on spinal cord injury (including SCI Health Storylines)
• Have cognitive impairments that impact memory, communication or ability to complete questionnaires.

Sponsors & Collaborators

• University of British Columbia: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

GF Strong Rehabilitation Center

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Related Publications (1)

• Mortenson WB, Mills PB, Adams J, Singh G, MacGillivray M, Sawatzky B. Improving Self-Management Skills Among People With Spinal Cord Injury: Protocol for a Mixed-Methods Study. JMIR Res Protoc. 2018 Nov 14;7(11):e11069. doi: 10.2196/11069.

  PMID: 30429114 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ben Mortenson, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since it is not possible to blind the participants or the interventionists, a single blind study design will be employed in which data collectors are blinded to participants' group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Mixed-methods, rater-blinded, randomized controlled trial with a stepped wedge design (i.e., delayed intervention control group). The qualitative portion will consist of semi-structured interviews with a sub-sample of the participants.

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 4, 2017
• Study Start: January 8, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)