NCT03404882

Brief Summary

The aim of the project is to conduct a four arm randomized controlled pilot trial to evaluate the effectiveness of an innovative peer support program that incorporates leadership training, mentorship, recognition, reward systems and supportive/reminder text messaging for patients discharged from acute (hospital) care. Methods and analysis: This is a prospective, rater-blinded, four arm randomized controlled trial. 180 patients discharged from acute psychiatric care in Edmonton, Alberta, Canada will be randomized to one of four conditions: treatment as usual follow-up care, enrollment in usual follow-up care plus daily supportive/reminder text messages, enrollment in a peer support system plus daily supportive/reminder text messages or enrollment in a peer support system without daily supportive text messages. Patients in each group will complete evaluation measures (e.g., recovery, general symptomatology, functional outcomes) at baseline, six and twelve weeks \& six and 12 months. Service utilization data and data regarding the experience of the peer support workers will also be collected. Data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. We hypothesize that patients enrolled in the peer support system plus daily supportive/reminder text messages condition will achieve superior outcomes in comparison to other groups. Peer support worker experience will be derived from exploratory data analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

January 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

January 8, 2018

Last Update Submit

April 9, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Core Outcome Measure

    Core outcome measure has 34 question measure covering 5 sub-scales * Relation to self and others * Daily living and role functioning * Depression and anxiety * Impulsive and addictive behaviour * Psychosis Sub-scale and overall mean scores also range from 0 to 4. Four of the five subscale scores and the BASIS-32 average are computed by averaging the ratings for component items using the number of non-missing items as the denominator. The score range from 0 to 128

    6 & 12 Weeks and 6 $ 12 Months

  • Changes in Health of Nations Outcome Scale (HoNOS) score from Baseline

    HoNOS measures the symptom severity and social functioning across time. It has 12 items that measure behaviour, impairment, symptoms and social functioning. The items are rated on a scale of 0-4 and the results or changes in ratings are known as outcomes and may be attributed to services provided. The scores range from 0 to 48.

    6 & 12 Weeks and 6 $ 12 Months

Secondary Outcomes (10)

  • Perceived Discrimination Scale score

    6 & 12 Weeks and 6 & 12 Months

  • World Health Organization Quality of Life Brief instrument (WHOQOL-BREF) score

    6 & 12 Weeks and 6 $ 12 Months

  • Patient Satisfaction/Experience Questionnaire

    6 & 12 Months

  • Rates of Health services utilization

    6 & 12 Months

  • Cost of Health services utilized

    6 & 12 Months

  • +5 more secondary outcomes

Study Arms (4)

text messaging plus peer support arm

EXPERIMENTAL

Patients will be assigned a peer support worker who will visit them during the last week of their inpatient stay to introduce themselves and build rapport before patients are discharged into the community. The peer support workers will visit the participants up to eight times over a six month period. The peer support workers will offer the opportunity for interactive text message support for six months. In addition to peer support, participants in this arm of the study will receive daily supportive text messages from an automated online application and reminder text messages for their community clinic/program appointments.

Behavioral: Supportive/reminder text messaging plus peer support

supportive/reminder text message only arm

ACTIVE COMPARATOR

Patients in the supportive/reminder text message only arm of the study will receive daily supportive text messages from the automated online application and reminder text messages for their community clinic/program appointments.

Behavioral: Supportive/reminder text messaging

Control arm

NO INTERVENTION

Patients in the control arm of the study will receive the usual follow-up appointment offered to all patients who are discharged from acute care. However, they will not receive peer support or supportive/reminder text messages.

peer support only arm

ACTIVE COMPARATOR

Patients will be assigned a peer support worker who will visit them during the last week of their inpatient stay to introduce themselves and build rapport before patients are discharged into the community. The peer support workers will visit the participants up to eight times over a six month period. The peer support workers will offer the opportunity for interactive text message support for six months. Patients will not receive daily supportive/reminder text messages

Behavioral: Peer support only

Interventions

Regular supportive/reminder text message will be delivered to patients who will also receive face to face and interactive text message support from peer support workers

text messaging plus peer support arm

Regular supportive/reminder text message will be delivered to patients who will NOT receive any face to face or interactive text message support from peer support workers

supportive/reminder text message only arm

face to face support from peer support workers but no interactive or daily supportive/reminder text messages

peer support only arm

Eligibility Criteria

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

You may qualify if:

  • Patients who are 18-65 years of age, able to provide informed written consent, have been diagnosed with an enduring mental health condition and are ready for discharge from an acute care facility within the Edmonton Zone with community mental health follow-up.

You may not qualify if:

  • Patients are also ineligible if they do not consent to take part in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Royal Alex Hospital

Edmonton, Alberta, T5H3V9, Canada

Location

Alberta Hospital

Edmonton, Alberta, T5J2J7, Canada

Location

Misericordia Community Hospital

Edmonton, Alberta, T5R4H5, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G2R3, Canada

Location

Grey Nuns Hospital

Edmonton, Alberta, T6L5X8, Canada

Location

Related Publications (24)

  • Proudfoot JG, Jayawant A, Whitton AE, Parker G, Manicavasagar V, Smith M, Nicholas J. Mechanisms underpinning effective peer support: a qualitative analysis of interactions between expert peers and patients newly-diagnosed with bipolar disorder. BMC Psychiatry. 2012 Nov 9;12:196. doi: 10.1186/1471-244X-12-196.

    PMID: 23140497BACKGROUND
  • Jacobson N, Trojanowski L, Dewa CS. What do peer support workers do? A job description. BMC Health Serv Res. 2012 Jul 19;12:205. doi: 10.1186/1472-6963-12-205.

    PMID: 22812608BACKGROUND
  • Onken SJ, Craig CM, Ridgway P, Ralph RO, Cook JA. An analysis of the definitions and elements of recovery: a review of the literature. Psychiatr Rehabil J. 2007 Summer;31(1):9-22. doi: 10.2975/31.1.2007.9.22.

    PMID: 17694711BACKGROUND
  • Myrick K, Del Vecchio P. Peer support services in the behavioral healthcare workforce: State of the field. Psychiatr Rehabil J. 2016 Sep;39(3):197-203. doi: 10.1037/prj0000188. Epub 2016 May 16.

    PMID: 27183186BACKGROUND
  • Chinman M, George P, Dougherty RH, Daniels AS, Ghose SS, Swift A, Delphin-Rittmon ME. Peer support services for individuals with serious mental illnesses: assessing the evidence. Psychiatr Serv. 2014 Apr 1;65(4):429-41. doi: 10.1176/appi.ps.201300244.

    PMID: 24549400BACKGROUND
  • Lloyd-Evans B, Mayo-Wilson E, Harrison B, Istead H, Brown E, Pilling S, Johnson S, Kendall T. A systematic review and meta-analysis of randomised controlled trials of peer support for people with severe mental illness. BMC Psychiatry. 2014 Feb 14;14:39. doi: 10.1186/1471-244X-14-39.

    PMID: 24528545BACKGROUND
  • Silver J, Nemec PB. The role of the peer specialists: Unanswered questions. Psychiatr Rehabil J. 2016 Sep;39(3):289-91. doi: 10.1037/prj0000216.

    PMID: 27618464BACKGROUND
  • Agyapong VI, Ahern S, McLoughlin DM, Farren CK. Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial. J Affect Disord. 2012 Dec 10;141(2-3):168-76. doi: 10.1016/j.jad.2012.02.040. Epub 2012 Mar 29.

    PMID: 22464008BACKGROUND
  • Agyapong VIO, Juhas M, Ohinmaa A, Omeje J, Mrklas K, Suen VYM, Dursun SM, Greenshaw AJ. Randomized controlled pilot trial of supportive text messages for patients with depression. BMC Psychiatry. 2017 Aug 2;17(1):286. doi: 10.1186/s12888-017-1448-2.

    PMID: 28768493BACKGROUND
  • Agyapong VI, McLoughlin DM, Farren CK. Six-months outcomes of a randomised trial of supportive text messaging for depression and comorbid alcohol use disorder. J Affect Disord. 2013 Oct;151(1):100-4. doi: 10.1016/j.jad.2013.05.058. Epub 2013 Jun 22.

    PMID: 23800443BACKGROUND
  • Agyapong VI, Mrklas K, Juhas M, Omeje J, Ohinmaa A, Dursun SM, Greenshaw AJ. Cross-sectional survey evaluating Text4Mood: mobile health program to reduce psychological treatment gap in mental healthcare in Alberta through daily supportive text messages. BMC Psychiatry. 2016 Nov 8;16(1):378. doi: 10.1186/s12888-016-1104-2.

    PMID: 27821096BACKGROUND
  • Gurol-Urganci I, de Jongh T, Vodopivec-Jamsek V, Atun R, Car J. Mobile phone messaging reminders for attendance at healthcare appointments. Cochrane Database Syst Rev. 2013 Dec 5;2013(12):CD007458. doi: 10.1002/14651858.CD007458.pub3.

    PMID: 24310741BACKGROUND
  • Alberta AH-G of. Valuing mental health: Next steps: Alberta Health website [Internet]. [cited 2018 Jan 3]. Available from: http://www.health.alberta.ca/initiatives/Mental-Health-Review.html

    BACKGROUND
  • Edmonton C of. 2016 Municipal Census Results [Internet]. 2017 [cited 2017 Sep 14]. Available from: https://www.edmonton.ca/city_government/facts_figures/municipal-census-results.aspx

    BACKGROUND
  • Giffort D, Schmook A, Woody C, Vollendorf C, Gervain M. Recovery Assessment Scale. Cambridge, MA: Human Services Research Institute; 1995

    BACKGROUND
  • Major B, O'Brien LT. The social psychology of stigma. Annu Rev Psychol. 2005;56:393-421. doi: 10.1146/annurev.psych.56.091103.070137.

    PMID: 15709941BACKGROUND
  • Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

    PMID: 15085902BACKGROUND
  • What is HoNOS? [Internet]. [cited 2018 Jan 4]. Available from: http://www.rcpsych.ac.uk/traininpsychiatry/conferencestraining/resources/honos/whatishonos.aspx

    BACKGROUND
  • Eisen SV, Normand SL, Belanger AJ, Spiro A 3rd, Esch D. The Revised Behavior and Symptom Identification Scale (BASIS-R): reliability and validity. Med Care. 2004 Dec;42(12):1230-41. doi: 10.1097/00005650-200412000-00010.

    PMID: 15550803BACKGROUND
  • World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.

    PMID: 24141714BACKGROUND
  • Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products. WHO Technical Report Series, No. 850, Annex 3 - WHO Expert Committee on Selection and Use of Essential Medicines, Sixth Report, 1993 [Internet]. [cited 2017 Nov 22]. Available from: http://apps.who.int/medicinedocs/en/d/Jwhozip13e/

    BACKGROUND
  • Sokol R, Fisher E. Peer Support for the Hardly Reached: A Systematic Review. Am J Public Health. 2016 Jul;106(7):e1-8. doi: 10.2105/AJPH.2016.303180. Epub 2016 May 19.

  • Shalaby R, Vuong W, Eboreime E, Surood S, Greenshaw AJ, Agyapong VIO. Patients' Expectations and Experiences With a Mental Health-Focused Supportive Text Messaging Program: Mixed Methods Evaluation. JMIR Form Res. 2022 Jan 11;6(1):e33438. doi: 10.2196/33438.

  • Urichuk L, Hrabok M, Hay K, Spurvey P, Sosdjan D, Knox M, Fu A, Surood S, Brown R, Coulombe J, Kelland J, Rittenbach K, Snaterse M, Abba-Aji A, Li XM, Chue P, Greenshaw AJ, Agyapong VIO. Enhancing peer support experience for patients discharged from acute psychiatric care: protocol for a randomised controlled pilot trial. BMJ Open. 2018 Aug 17;8(8):e022433. doi: 10.1136/bmjopen-2018-022433.

MeSH Terms

Conditions

DepressionBipolar DisorderSchizophrenia

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to treatment group allocation by not involving them in discussions about study participants and not granting them access to the database which contains the randomization code. In addition, study participants will be asked not to reveal their treatment allocation to their assessor. Moreover, these assessors will not be involved in data analysis. To test the success of blinding we will ask the assessor to guess the treatment group for each participant at six and 12-month follow-up. After data collection is complete all data will undergo a blind review for the purposes of finalizing the planned analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This will be a longitudinal, prospective, parallel design, three arm, rater-blinded randomized clinical trial with a recruitment period of six months and an observation period of 12 months for each participant.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 19, 2018

Study Start

June 1, 2019

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations