NCT03709212

Brief Summary

Cardiovascular disease (CVD) remains the leading cause of death in patients with Chronic Kidney Disease (CKD). Patients who spend a lot of time being inactive have an increased chance of developing CVD. Thus, interventions that can help to increase the levels of physical activity in patients with CKD are needed. A recent study the investigators completed with kidney transplant participants showed a benefit from the investigators supervised exercise programme. However, the investigators results showed that 11 of the 18 patients who dropped out from the 12-month study were from black and minority ethnic groups. Some patient feedback from these participants suggested that cultural beliefs; including women not being comfortable to exercise in front of men in an exercise class environment, and difficulties around appropriate dress for exercise classes, contributed to some of these participants' decisions to withdraw from the study. This has prompted the investigators to investigate, the cultural influences that may contribute to patient decisions about partaking in physical activity and exercise training. The aim of this study is therefore to invite patients with CKD from the three most widely represented ethnic groups found in our South-East London Hospital Trust (Black African and African-Caribbean; South Asian, and White Caucasian patients) to discuss their beliefs and the cultural influences that may affect their decision on whether to engage with exercise and physical activity. Participants will complete a questionnaire on physical activity levels, and a questionnaire that looks at a patient's readiness to be involved in physical activity, prior to attending interviews or group discussions. The questionnaires will be translated for use with non-English speaking participants and will be used to ensure we get views on physical activity from those participants who are active and not, and ready to be involved in physical activity, and not. A combination of individual interviews and group discussions will then be used to explore the understanding of the terms 'physical activity' and 'exercise', and cultural barriers to participation. The investigators will have interpreters present for all discussions, undertaken in the community. The work from this pilot study will be used to inform and design a larger multi-centre study with an aim to design physical interventions that are culturally sensitive, and appropriate for all patients with CKD in the United Kingdom.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 27, 2020

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

August 8, 2018

Last Update Submit

February 26, 2020

Conditions

Keywords

Chronic Kidney DiseasePhysical ActivityCultural influencesExercise

Outcome Measures

Primary Outcomes (2)

  • One-to-one semi-structured interview to explore participants experiences of living with Chronic Kidney Disease.

    To establish challenges and perceptions of living with this long term condition and how this has an impact on day to day life.

    Through study completion, an average of one year

  • One-to-one semi-structured interview to explore participants experience of exercise and physical activity

    Any difficulties/ barriers to exercise or physical activity determined by a qualitative interview. Experiences of the exercise and physical activity by a qualitative interview. Benefits to under taking physical activity and exercise by a qualitative interview. Facilities and opportunities available to undertake exercise of physical activity by a qualitative interview. Any cultural influences that may have influenced decisions to participate in physical activity and exercise by a qualitative interview.

    Through study completion, an average of one year

Secondary Outcomes (2)

  • Physical activity through General Practice Physical Activity Questionnaire (GPPAQ)

    Through study completion, an average of one year

  • Self-efficacy to regulate exercise

    Through study completion, an average of one year

Study Arms (7)

Individual semi-structured interview

20 participants will undergo individual semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this. Participants will be recruited from three ethnic backgrounds; Black African/ Caribbean, South Asian and White Caucasian.

Other: interviews

Focus Group 1

10 participants female black African/ African Caribbean ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.

Other: interviews

Focus Group 2

10 participants male Black African/ African Caribbean ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.

Other: interviews

Focus Group 3

10 participants female South Asian ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.

Other: interviews

Focus Group 4

10 participants male black South Asian ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.

Other: interviews

Focus Group 5

10 participants female White Caucasian ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.

Other: interviews

Focus Group 6

10 participants male White Caucasian ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.

Other: interviews

Interventions

20 participants will undergo individual semi-structured interviews, 60 will undergo one of 6 focus groups comprising of 10 participants of the same gender and ethnicity.

Also known as: individual semi-structured, Focus groups
Focus Group 1Focus Group 2Focus Group 3Focus Group 4Focus Group 5Focus Group 6Individual semi-structured interview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators aim to recruit up to 20 patients (for the individual interviews) and 60 patients (for the 6 single-sex focus groups), aged over 18 years or over with CKD from the 3 identified ethnic groups, will be recruited to the study. Each patient must have met the inclusion and exclusion criteria at entry level to the study. For focus groups the investigators will aim to meet with six to twelve participants per group. Appropriate topic guides will be developed and discussed with the patient advisory group, and the steering group. The investigators will continue with individual interviews and focus groups until data saturation is reached, there is no new data, no new themes, no new coding and the investigators are able to replicate the study.

You may qualify if:

  • Participants with a diagnosis of CKD that are representative of one of the 3 ethnic groups that will be studied (Black African and African-Caribbean; South Asian, and White Caucasian patients)
  • Age \> 18 years of age
  • able to provide Informed consent

You may not qualify if:

  • Uncontrolled medical condition (e.g. uncontrolled angina)
  • Unstable psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

  • Mayes J, Castle EM, Greenwood J, Ormandy P, Howe PD, Greenwood SA. Cultural influences on physical activity and exercise beliefs in patients with chronic kidney disease: 'The Culture-CKD Study'-a qualitative study. BMJ Open. 2022 Jan 11;12(1):e046950. doi: 10.1136/bmjopen-2020-046950.

MeSH Terms

Conditions

Renal Insufficiency, ChronicMotor Activity

Interventions

Interviews as TopicFocus Groups

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sharlene A Greenwood, PhD, BSc

    King's College Hospital NHS Trust

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2018

First Posted

October 17, 2018

Study Start

May 31, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

February 27, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

The study group plans to make anonymised data available as supplementary text when the study is published as an online manuscript. For example Plos one

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
within 12 months of study completion
Access Criteria
with open access publication

Locations