Do Educational Digital Films Enhance Patient COPD Outcomes? | NCT03263754

Studies
Do Educational Digital Films Enhance Patient COPD Outcomes?

NCT03263754

Sponsor

Aberystwyth University

Status

Completed

Last Update Posted

Jan 11, 2019Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Pocket Medic
Pulmonary Rehabilitation

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Jul 2018Actual

Completion Date

Jul 2018Actual

First Submitted Date

Aug 24, 2017

First Submission Date that Met QC Criteria

Aug 25, 2017

First Posted Date

Aug 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2019

Last Update Posted Date

Jan 11, 2019Actual

Name	Class
Hywel Dda Health Board	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) refers to a group of lung conditions characterized by airways inflammation, small airways obstruction and progressive loss of lung function. There are 900,000 people diagnosed with COPD in England and Wales but allowing for under-diagnosis, the true prevalence could be 1.5 million. Sufferers are extensive health care users; where COPD is the second most common cause of emergency hospital admission in the United Kingdom with direct National Health Service costs over £800 million per year. Pulmonary Rehabilitation programs (PRPs) aim to provide education and support for patients whilst improving clinical outcomes, however, attendance to these programs can be low.

This study aims to trial a series of digital films aimed at educating patients about their condition from the comfort of their own home. Approximately 80 patients eligible for PR will be allocated to an experimental condition to receive a series of 10 digital films alongside their standard 7-week PR, solely to receive 10 digital films, or to a control condition in the form of standard PR (no digital films). Outcome measures such as PR attendance, hospital admissions, quality of life (QoL), disease knowledge, psychological need satisfaction and motivation will be measured pre and post. Analysis of this data between the experimental and control conditions pre-post intervention will provide useful information regarding the efficacy of digital film prescriptions as an adjunct to usual PR, or on its own, and the role this may play is encouraging PR attendance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Behavioral: Pocket Medic Behavioral: Pulmonary Rehabilitation
Control	Active Comparator		Behavioral: Pulmonary Rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pocket Medic	Behavioral	10 short digital films utilising self-determination theory aiming to increase patient self-management	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Disease Knowledge	Scores on Bristol COPD Knowledge Questionnaire	10 weeks and 6 months
Service Utilization	Number of General Practioner visits and hospitalizations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible for pulmonary rehabilitation in Hywel Dda University Health Board.

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liam Knox	Aberystwyth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glangwilli Hospital		Carmarthen	Carmarthenshire	SA31 2AF	United Kingdom
Prince Phillip Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided