NCT04076384

Brief Summary

The study will develop and evaluate the effectiveness of a team-based follow-up program in general practice (GP) among people with chronic conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2.4 years

First QC Date

August 26, 2019

Last Update Submit

February 28, 2022

Conditions

Diabetes Type 2COPD

Outcome Measures

Primary Outcomes (1)

  • Patient Activation Measure (PAM-13)

    The Patient Activation Measure instrument capture patient's knowledge, skills and confidence for self-management living with chronic conditions.It has four response categories with scores from 1 to 4: "strongly disagree" (1), "disagree" (2), "agree" (3) and "agree strongly" (4). The scale scores are transformed to a 0 to 100 scale (0 = lowest activation level, 100 = highest activation level).

    12 months

Secondary Outcomes (8)

  • HbA1c

    12 months

  • Problem Areas in Diabetes Scale (PAID-5)

    12 months

  • The World Health Organization 5-item Well-Being Index (WHO-5)

    12 months

  • Quality of Life-BREF 2-Item questionnaire

    12 months

  • The EuroQol EQ-5D-5L

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Team-based consultations

EXPERIMENTAL

Guided Self-Determination

Behavioral: Guided Self-Determination

Standard care

EXPERIMENTAL

Standard consultation

Behavioral: Standard care

Interventions

Guided Self-DeterminationBEHAVIORAL

Structured team-based consultations

Team-based consultations
Standard careBEHAVIORAL

Standard consultations

Standard care

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 20-80 years with FINDRISC score ≥15
  • Body Mass Index ≥ 30
  • Manifest T2DM (HbA1c ≥48 mmol/mol (6,5%))
  • Positive smoking status (risk for COPD)
  • Manifest COPD (spirometry value: FEV1/FVC \< 0,7).

You may not qualify if:

  • Severe somatic disease (cancer, end stage renal disease)
  • Severe psychiatric diagnosis or dementia
  • Patients who do not understand nor speak Norwegian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Norway University of Applied Sciences

Bergen, Hordaland, 5020, Norway

Location

Related Publications (2)

  • Kolltveit BH, Oftedal BF, Thorne S, Lomborg K, Graue M. Experiences of an interprofessional follow-up program in primary care practice. BMC Health Serv Res. 2024 Feb 23;24(1):238. doi: 10.1186/s12913-024-10706-9.

    PMID: 38395910DERIVED

  • Kolltveit BH, Graue M, Borge CR, Frisk B. Patients' experiences with participating in a team-based person-centred intervention for patients at risk of or diagnosed with COPD in general practice. Pilot Feasibility Stud. 2023 Sep 25;9(1):164. doi: 10.1186/s40814-023-01398-9.

    PMID: 37749601DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Pulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Beate-Christin H Kolltveit, Ph.D

    Western Norway University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2019

First Posted

September 3, 2019

Study Start

August 19, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)