Condition category
Urological and Genital Diseases
Date applied
18/08/2016
Date assigned
26/09/2016
Last edited
27/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The purpose of this study is to investigate the relationships between depression, patients’ feelings about having kidney disease, the symptoms they experience, and how active they are. This study will help researchers to understand how kidney disease makes people feel in themselves and how it affects their quality of life. It is hoped that this will lead to new ways of helping patients cope better with living with kidney disease.

Who can participate?
Adults (aged at least 18) with chronic kidney disease.

What does the study involve?
Each participant is asked to complete a survey made up of 8 sections. Each section is a separate, simple questionnaire. The participants are given the survey to take home so that they can complete it in their own time. They are all given a stamped addressed envelope to post it back. The survey asks questions about how a person with kidney disease feels about their condition and how it impacts on their quality of life.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University Hospitals of Leicester (UK)

When is the study starting and how long is it expected to run for?
August 2016 to March 2019

Who is funding the study?
1. University of Leicester (Doctorate in Clinical Psychology grant)
2. Loughborough University (Commonwealth PhD studentship)

Who is the main contact?
Dr Alice Smith

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alice Smith

ORCID ID

http://orcid.org/0000-0002-9234-9060

Contact details

Leicester Kidney Exercise Team
Academic Unit
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1 1st February 2016

Study information

Scientific title

Physical activity, depression and illness perceptions in CKD: a cross-sectional survey study

Acronym

ADAPT

Study hypothesis

There is a paucity of research on the illness perception of individuals living with chronic kidney diseases (CKD) and its association with health behaviour; research in this field will assist to understand if illness perception is predictive of the levels of physical activity in individuals with CKD.

The purpose of this study is to investigate the relationships between depression, patients’ feelings about having CKD, the symptoms they experience, and how active they are. This study will help researchers to understand how kidney disease makes people feel in themselves and how it affects their quality of life. It is hoped that this will lead to new ways of helping patients cope better with living with kidney disease.

Ethics approval

London Queen Square Research Ethics Committee, 06/06/2016, ref: 16/LO/0980

Study design

Cross-sectional survey design

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

See additional files

Condition

Chronic kidney disease

Intervention

People with CKD are invited to complete a survey consisting of 8 sections, each of which is a separate simple questionnaire. The survey will be given to participants to fill in at home, and they will then return it to the researchers in a stamped addressed envelope. They are also asked for their permission for a researcher to extract some information from their medical records (recent blood and urine test results, medications, past medical history including any other health conditions).

The survey consists of the following sections:
Section 1: Some questions about you
Section 2: A questionnaire about how you feel about Chronic Kidney Disease
Section 3: A questionnaire about your mood over the last 2 weeks
Section 4: A questionnaire about your physical activity over the last 7 days
Section 5: A questionnaire about your ability to carry out day-to-day activities
Section 6: A questionnaire about the symptoms you experience
Section 7 : A questionnaire about how tired you have felt over the last week
Section 8: A questionnaire about your quality of life

There will be no further follow up of the participants. A descriptive analysis of the results will be carried out, and associations and relationships between the questionnaire responses and clinical parameters using correlation and regression explored.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Association between self-reported physical activity measured using the International Physical Activity Questionnaire Short Form (IPAQ-SF) and perception of chronic kidney disease measured using the Illness Perception Questionnaire (IPQ-R) at a single time point.

Secondary outcome measures

1. Depression measured using the Beck Depression Inventory (BDI-II)
2. Physical capacity measured using the Duke Activity Status Index (DASI)
3. Experience of symptoms measured using the Kidney Symptom Questionnaire (KSQ)
4. Fatigue levels measured using the Leicester Kidney Fatigue Scale
5. Quality of Life measured using the EuroQOL 5 Dimension scale (EQ5D)
6. Associations between the above questionnaires and:
6.1. Clinical markers of disease severity (routine blood and urine test results; prescribed medications; comorbidities)
6.2. Demographic indicators measured by questionnaire (age, sex, ethnicity, educational level, smoking status)

Overall trial start date

01/08/2016

Overall trial end date

15/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1.The participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 years or above
3. With chronic kidney diseases (including diabetic kidney disease) attending outpatient clinics

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size is 44 (n = 44)

Participant exclusion criteria

1. Individuals who are unable to understand, read and write English
2. Unable to consent for any other reason

Recruitment start date

01/08/2016

Recruitment end date

01/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester Kidney Exercise Team Academic Unit
Leicester
Le5 4Pw
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust

Sponsor details

Research and Innovation Office
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
01162584109
uhlsponsor@uhl-tr.nhs.uk

Sponsor type

Research council

Website

Funders

Funder type

University/education

Funder name

University of Leicester

Alternative name(s)

UoL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Loughborough University

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/09/2016: Internal review