NCT05192083

Brief Summary

COPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care. The current proposal is to evaluate the feasibility and acceptability of a pilot trial of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

November 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

November 27, 2021

Last Update Submit

April 11, 2022

Conditions

Keywords

COPDSelf-managementSupportSmartphone-based

Outcome Measures

Primary Outcomes (1)

  • Change from baseline COPD-related quality of life

    COPD symptoms and impacts and activity level were measured by an 8-item COPD Assessment Test. Total scores range from 0 to 40, with higher scores denoting a more severe impact of COPD on a patient's life.

    Baseline, Week 8

Secondary Outcomes (12)

  • Change from baseline patient activation

    Baseline, Week 8

  • Change from baseline self-efficacy for self-management

    Baseline, Week 8

  • Change from baseline acceptance of illness

    Baseline, Week 8

  • Change from baseline medication adherence

    Baseline, Week 8

  • Change from baseline physical activity level

    Baseline, Week 8

  • +7 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

The intervention group will receive a smartphone-based self-management support programme, including a 30-min face-to-face or online session at baseline, 3 phone calls (week 2, week 4 and week 6) and 2-month mobile messages in addition to usual care.

Behavioral: Self-management and Support

Interventions

A smartphone-based self-management support programme includes a 30-min face-to-face or online session at baseline, 3 phone calls and 2-month mobile messages

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years and above
  • Diagnosis with COPD
  • General condition stable
  • Able to speak and read Chinese
  • Able to complete the self-administered questionnaire
  • Able to use instant messages such as WhatsApp or WeChat
  • Mental, cognitive and physically fit for joining the trial as determined by the clinician or responsible investigator
  • Signed informed consent

You may not qualify if:

  • Skeletal fragility
  • Serious active infection
  • Inability to walk
  • Severe respiratory insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen mary Hospital

Hong Kong, 852, Hong Kong

RECRUITING

Related Publications (4)

  • Buttery SC, Zysman M, Vikjord SAA, Hopkinson NS, Jenkins C, Vanfleteren LEGW. Contemporary perspectives in COPD: Patient burden, the role of gender and trajectories of multimorbidity. Respirology. 2021 May;26(5):419-441. doi: 10.1111/resp.14032. Epub 2021 Mar 9.

    PMID: 33751727BACKGROUND
  • Jolly K, Sidhu MS, Hewitt CA, Coventry PA, Daley A, Jordan R, Heneghan C, Singh S, Ives N, Adab P, Jowett S, Varghese J, Nunan D, Ahmed K, Dowson L, Fitzmaurice D. Self management of patients with mild COPD in primary care: randomised controlled trial. BMJ. 2018 Jun 13;361:k2241. doi: 10.1136/bmj.k2241.

    PMID: 29899047BACKGROUND
  • Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health. 2015 Mar 18;36:393-415. doi: 10.1146/annurev-publhealth-031914-122855.

    PMID: 25785892BACKGROUND
  • Redfern J, Hyun K, Singleton A, Hafiz N, Raeside R, Spencer L, Carr B, Caterson I, Cullen J, Ferry C, Santo K, Hayes A, Leung RWM, Raadsma S, Swinbourne J, Cho JG, King M, Roberts M, Kok C, Jenkins C, Chow C. ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial. BMJ Open. 2019 Mar 1;9(3):e023863. doi: 10.1136/bmjopen-2018-023863.

    PMID: 30826759BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Self-ManagementPalliative Care

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesPatient CareTherapeutics

Study Officials

  • Agnes YK Lai, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes YK Lai, PhD

CONTACT

Asa Choi, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Self-management education and support
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 27, 2021

First Posted

January 14, 2022

Study Start

January 2, 2022

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Need to obtain consent from patients before agreeing to share individual participants data.

Shared Documents
STUDY PROTOCOL
Time Frame
When study finished
Access Criteria
The minimal anonymized dataset will be available upon request to interested researchers. For interested researchers, please contact, Ms Asa Choi (email asachoi@hku.hk), (School of Nursing, The University of Hong Kong) for further information.

Locations