NCT03660644

Brief Summary

The aim of this feasibility study is to identify the acceptability of an intervention designed to promote physical activity following pulmonary rehabilitation for individuals with Chronic Obstructive Pulmonary Disease (COPD). Participants in the intervention group will be provided with pedometers and step diaries and added to a WhatsApp group with other graduates of pulmonary rehabilitation for 52 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 17, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

June 13, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 20, 2020

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

May 17, 2018

Last Update Submit

February 19, 2020

Conditions

Keywords

COPDPhysical ActivityPulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Acceptability of the intervention

    The number of patients who comply with the intervention will be measured

    55 weeks

Secondary Outcomes (15)

  • Recruitment rates

    Up to 26 weeks (approximately)

  • Consent rates

    Up to 26 weeks (approximately)

  • Attrition rates

    Up to 55 weeks (study completion)

  • Semi-structured telephone interviews with subsets of patients

    At relevant intervals up to 55 weeks (study completion)

  • Focus groups with health care professionals

    At relevant intervals up to 55 weeks (study completion)

  • +10 more secondary outcomes

Study Arms (2)

WhatsApp, Pedometer and Step Diary

EXPERIMENTAL

Pedometer, step diary and WhatsApp following pulmonary rehabilitation

Behavioral: WhatsApp, Pedometer and Step Diary

Control

NO INTERVENTION

Usual care following pulmonary rehabilitation.

Interventions

Participants will be provided with a daily step diary and added to a group chat on WhatsApp. The group chat will be populated by other members of pulmonary rehabilitation programme (cluster) and the WhatsApp group leader will encourage participants to keep active. Participants will be encouraged to record the number of steps walked in a paper diary at the end of each day (i.e. prior to bedtime). This diary will simply have three columns: day of the week; number of steps; comments (optional). The intervention will last 52 weeks.

WhatsApp, Pedometer and Step Diary

Eligibility Criteria

Age30 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cluster level
  • Pulmonary rehabilitation programmes within Lincolnshire Community Health Services (NHS trust).
  • Permission from the lead healthcare professionals of the pulmonary rehabilitation programme for the programme to be involved in the study.
  • Patient level
  • Adults (age range: 30-100 years) with COPD who are enrolled in pulmonary rehabilitation within Lincolnshire Community Health Services (NHS trust).
  • Provide informed consent for their outcome data to be collected.
  • Patients (for telephone interviews)
  • Have access to a telephone.
  • Adults (age range: 30-100 years) with COPD who are enrolled in pulmonary rehabilitation within Lincolnshire community health services (NHS trust).
  • Provide informed consent to participate in a telephone interview (including patients who do/do not consent for their outcome data to be collected).
  • Health care professionals
  • Involved in delivering the pulmonary rehabilitation programmes allocated to the Intervention Group within Lincolnshire Community Health Services (NHS trust).
  • Provide informed consent to participate in a focus group.
  • WhatsApp group leaders
  • Volunteers (who were members of local COPD support groups, whom held the position of Chair, Treasurer or Secretary, or were ordinary members, and in general, sufficiently stable to be a proactive and regular member of the group)
  • +1 more criteria

You may not qualify if:

  • Cluster level
  • Pulmonary rehabilitation programmes which are not within Lincolnshire Community Health Services (NHS trust).
  • The lead health care professionals of the pulmonary rehabilitation programmes are unwilling for the programme to be involved in the study.
  • Patient level
  • Not enrolled on a pulmonary rehabilitation programme within Lincolnshire Community Health Services (NHS trust) or those who drop out of pulmonary rehabilitation following enrolment.
  • Unable/unwilling to provide informed consent for their outcome data to be collected.
  • Involved in another research study including the use of an intervention to promote physical activity.
  • Patients (telephone interviews)
  • Do not have access to a telephone.
  • Not enrolled on a pulmonary rehabilitation programme within Lincolnshire Community Health Services (NHS trust) or those who drop out of pulmonary rehabilitation following enrolment.
  • Unable/unwilling to provide informed consent to participate in a telephone interview.
  • Health care professionals
  • Not involved in delivering the pulmonary rehabilitation programmes allocated to the Intervention Group.
  • Unable/unwilling to provide informed consent to participate in a focus group.
  • WhatsApp group leaders
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS pulmonary rehabilitation clinics across Lincolnshire

Lincoln, Lincolnshire, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hayley Robinson, MSc

    University of Lincoln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Physiotherapists will be aware of the allocation of the programmes (not possible to blind) as they will be involved with delivering information/training of the intervention components. However, a researcher blinded to group allocation will perform the quantitative analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

September 6, 2018

Study Start

June 13, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 20, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations