How Does the Spirituality of Patients With Type 2 Diabetes Influence Their Self-management?

NCT02661165 | Completed

• 1 other identifier: USouthampton
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study is researching how the spirituality of a group of British patients with type 2 diabetes (T2D), impacts their approach to the self-management of their condition. Bio-statistical markers will be taken from consenting participants' Clinic database records. Qualitative interviews will be conducted with participants, and the results analysed and interpreted, alongside their bio-statistical markers. Results will be presented in healthcare peer reviewed journals and conferences, to inform clinicians how patients' self-management of their T2D is influenced by their spirituality.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• The self-management Interviews to identify if and how patients' spirituality influences their diet and exercise.

  An exploratory study using qualitative data only to identify if and how patients' spirituality influences their diet and exercise, both of which are key to good diabetes control, and the prevention of diabetic complications in the long term. (No quantitative data will be collected, and as such no outcome measures will be collected). Interviews will utilize the biographical narrative interpretive method to reveal how beliefs may influence diet and exercise. Each interview may last up to 3 hours. Each participant will be interviewed up to 3 times (approximately 9 hours of interviewing per participant). Interviews will be transcribed verbatim. Themes will be generated, coded and interpreted. Results will be the researchers interpretive analysis of the qualitative data generated, and the themes that emerge.

  58 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with T2D from a community or primary care clinic

You may qualify if:

• Speak English
• Have had T2D at least 6 months.
• Have read the Participant Information Sheet, explaining this study is regarding T2D, spirituality, coping and self-management.
• Gives consent to access their diabetes details that are stored on a Clinic database.
• Gives consent to recorded interviews.

You may not qualify if:

• Not speak English.
• Have had T2D less than 6 months.
• Have read the Participant Information Sheet, and decided they are not comfortable talking about their T2D, or spirituality, or coping or their self-management.
• Not consenting to data collection from Clinic records.
• Clinic records have not been kept (e.g. is a new patient to their family doctor).
• Consent is withdrawn from the study (which could be any stage).

Sponsors & Collaborators

• Natasha Duke: lead
• University of Southampton: collaborator

Study Sites (1)

University of Southampton

Southampton, Hampshire, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Natasha Duke

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral Student

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: January 22, 2016
• Study Start: June 1, 2016
• Primary Completion: April 26, 2018
• Study Completion: April 26, 2018
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)