NCT05994651

Brief Summary

Aim: In this study, it was aimed to evaluate the effect of the tidal model on distress, self-management and psychological well-being in individuals with diabetes. It is thought that this study will contribute to the literature, nursing profession and patients with diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

July 10, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

Same day

First QC Date

August 8, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

Diabetes diseasePsychiatric NursingTidal ModelPsychological well-beingDistressSelf-Management

Outcome Measures

Primary Outcomes (3)

  • 1. The effect of using the tidal model on the distress status of individuals with diabetes will be evaluated.

    The DDS is a 17-item psychological measurement tool that uses a Likert scale with each item scored from 1 (no distress) to 6 (serious distress) to reflect distress experienced over the last month. The total score is calculated by dividing the sum of the answers by 17. A score of ≥3 is defined as T2DM-related distress. There are four subscales and subscale scores are also calculated by dividing the sum of subscale answers to the total question count of the subscale. Subscales are as follows: the emotional burden subscale with 5 questions, the physician-related distress subscale with 4 questions, the regimen-related distress subscale with 5 questions, and the interpersonal distress subscale with 3 questions.

    up to 6-10 weeks

  • The effect of using the tidal model on the self-management status of individuals with diabetes will be evaluated.

    There are 8 items in the original scale of the Diabetes Self-Management Perception Scale. High participation in these items indicates low self-efficacy. For this reason, the 3 items mentioned were reverse scored compared to the other items. The lowest score that can be obtained from the scale is 7, and the highest score is 35. A high total score indicates that the individual has good awareness of diabetes management

    up to 6-10 weeks

  • The effect of using the tidal model on the psychological well-being of individuals with diabetes will be evaluated.

    The scale is an 8-item 7-point Likert-type (1=totally disagree, 7=totally agree) self-assessment scale. High scores indicate higher psychological well-being.

    up to 6-10 weeks

Study Arms (2)

Tidal Model improvement model

EXPERIMENTAL

In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the research objectives.

Behavioral: Tidal Model improvement model

Tidal Model Control Group

NO INTERVENTION

Individuals in the control group will continue their lives.

Interventions

1. st interview Pre-assessment Application of measurement tools 2. nd meeting Orientation Concept of recovery, change phase of the individual, Holistic Evaluation, Creation of Personal Safety Plan 3. Interview Process planning Setting goals, Starting One-on-One Sessions 4th meeting Healing is possible, accepting his illness, overcoming change, emphasizing his strengths, instilling hope 5.-6. interview Empowerment Coping with crisis, reducing anxiety, relaxation exercises, individual roles, assertiveness, strengthening self-esteem 7.-8. Interview Maintaining control of life, taking responsibility for behavior, appropriate expression of anger, feeling, thinking and Taking responsibility for recovery, discovering behaviors 9th interview Creating a supportive environment Increasing new interactions, relationships, social skills 10th meeting Evaluation Finalizing the personal security plan, using new knowledge and behaviors in the healing journey, evaluation of the process

Tidal Model improvement model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with diabetes for at least 6 months, Individuals aged 18 and over will be included in the study.

You may not qualify if:

  • Patients with any psychiatric or neurological disorder that would prevent adequate communication will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Türkiye

Osmaniye, Korkut Ata University, 80000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Ejdane Coşkun

    Korkut Ata University Osmaniye, Center, Türkiye, 80000

    PRINCIPAL INVESTIGATOR
  • Ayşe İNEL MANAV

    Korkut Ata University Osmaniye, Center, Türkiye, 80000

    PRINCIPAL INVESTIGATOR
  • Derya Atik

    Korkut Ata University Osmaniye, Center, Türkiye, 80000

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 16, 2023

Study Start

July 10, 2023

Primary Completion

July 10, 2023

Study Completion

September 10, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Don't share

Locations