NCT03263754

Brief Summary

This study aims to assess the efficacy of Pocket Medic to promote self-management and pulmonary rehabilitation adherence in COPD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

August 24, 2017

Last Update Submit

January 10, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient engagement

    The level at which patients in the intervention arm watch the digital films

    10 weeks

  • Patient Adherence

    The level at which patients attend pulmonary rehabilitation sessions

    10 weeks

Secondary Outcomes (4)

  • Disease Knowledge

    10 weeks and 6 months

  • Service Utilization

    Baseline and 6 months

  • Psychological self-management

    10 weeks and 6 months

  • Understanding COPD self-management

    10 weeks and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Pocket MedicBehavioral: Pulmonary Rehabilitation

Control

ACTIVE COMPARATOR
Behavioral: Pulmonary Rehabilitation

Interventions

Pocket MedicBEHAVIORAL

10 short digital films utilising self-determination theory aiming to increase patient self-management

Intervention

PR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach

ControlIntervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for pulmonary rehabilitation in Hywel Dda University Health Board.

You may not qualify if:

  • Unwilling or unable to give informed consent
  • life expectancy of less than 6 months
  • unstable cardiovascular disease, dementia, cancers other than non-melanoma skins cancer
  • any condition that precludes patients using laptops or mobile phones (e.g. blind, deaf)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Glangwilli Hospital

Carmarthen, Carmarthenshire, SA31 2AF, United Kingdom

Location

Prince Phillip Hospital

Llanelli, Carmarthenshire, SA14 8QF, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Liam Knox

    Aberystwyth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 28, 2017

Study Start

September 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

January 11, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations