Physical activity, depression and illness perceptions in CKD
| ISRCTN | ISRCTN18308813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18308813 |
| Secondary identifying numbers | Version 1 1st February 2016 |
- Submission date
- 18/08/2016
- Registration date
- 26/09/2016
- Last edited
- 31/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Leicester Kidney Exercise Team
Academic Unit
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
 ORCID ID |
0000-0002-9234-9060 |
|---|
Study information
| Study design | Cross-sectional survey design |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | ISRCTN18308813_PIS_25Aug2016.doc |
| Scientific title | Physical activity, depression and illness perceptions in CKD: a cross-sectional survey study |
| Study acronym | ADAPT |
| Study objectives | 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(s) | London Queen Square Research Ethics Committee, 06/06/2016, ref: 16/LO/0980 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2016 |
| Completion date | 15/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size is 44 (n = 44) |
| Key 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 |
| Key exclusion criteria | 1. Individuals who are unable to understand, read and write English 2. Unable to consent for any other reason |
| Date of first enrolment | 01/08/2016 |
| Date of final enrolment | 01/08/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Unit
Leicester
LE5 4PW
United Kingdom
Sponsor information
Research council
Research and Innovation Office
Leicester General Hospital
Leicester
LE5 4PW
United Kingdom
| Phone | +44 1162584109 |
|---|---|
| uhlsponsor@uhl-tr.nhs.uk | |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- UoL
- Location
- United Kingdom
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Lboro
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 15/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 25/08/2016 | 26/09/2016 | No | Yes | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN18308813_PIS_25Aug2016.doc
- Uploaded 26/09/2016
Editorial Notes
31/10/2017: Internal review.
27/09/2016: Internal review.
