NCT04799860

Brief Summary

The study will support implementation of a health promotive work-way in primary care setting by using external and internal facilitators, with the aim to identify effective implementation strategies and to evaluate intervention uptake. Data will be collected from multiple perspecitves.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 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

First Submitted

Initial submission to the registry

March 4, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

March 4, 2021

Last Update Submit

December 9, 2025

Conditions

Keywords

implementationprimary careprocess evaluation

Outcome Measures

Primary Outcomes (4)

  • Change and trend from baseline documented codes in medical records

    specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity

    Change from baseline (6 months), through study completion up to 6 months after end of implementation support

  • Change and trend from baseline documented codes in medical records

    specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity

    Change from baseline (6 months), through study completion up to 18 months after end of implementation support

  • Change in S-NoMAD score (Swedish translation of NoMAD

    23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring

    Change from baseline S-Nomad score up to 4 to 6 months after end of study completion

  • Change in S-NoMAD score (Swedish translation of NoMAD

    23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring

    Change from baseline S-Nomad score up to 16 to 18 months after end of study completion

Secondary Outcomes (3)

  • Change in perceived clincial intervention by a study specific questionnaire

    Change from baseline up to 4 to 6 months after end of implementation support

  • Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.

    Change from baseline in AIM,IAM and FIM up to 4 to 6 months after end of implementation support

  • Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.

    Change from baseline in AIM,IAM and FIM up to 16 to18 months after end of implementation support

Other Outcomes (4)

  • Interviews to tailor strategies and evaluate implementation process

    Interviews pre-intervention and up to 3 to 6 months after end of implementation support

  • Interviews to evaluate implementation support, clinical process and thoughts about up-scaling

    Interviews pre-intervention and up to 16 to18 months after end of implementation support

  • Person centered processmapping

    At baseline

  • +1 more other outcomes

Study Arms (2)

health promotive work-way

EXPERIMENTAL

Six primary care units that voluntarily enrolls as experimental units. The units will receive implementation support based on previous research and tailored to the specific prerequisits and context for each unit. Strategies includes involvement of target groups; informationa and interactive education;use of external and internal facilitators tarined for the purpose; systematic feedback and learning dialogs during the project. The implementation support will take approximately 12 months.

Behavioral: health promotive work-way

Control

NO INTERVENTION

Six primary care centers of similar size and socioeconomic background in the population listed to each center.

Interventions

Clinical intervention: The patient is asked to fill in a screening form with life-style related questions. The caregiver takes adequate measures according to the recommendations of the national guideline and the filled in screeing form. The caregiver documents the measures taken. Implementation intervention as described previously: using tailored strategies to support implementation of the gudieline-based recommendations

health promotive work-way

Eligibility Criteria

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

You may qualify if:

  • being a caregiver meeting patients and/or
  • being assigned a role as internal or external facilitator in the project
  • years or older
  • visiting primary care units a specific time pre- or post implementation support
  • \* : having one or more unhealthy life-style habit 18 years or older
  • \* being a manager at a primary care unit or at higher level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Örebro County

Örebro, 70185, Sweden

Location

Related Publications (11)

  • Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.

    PMID: 25791983BACKGROUND
  • Wandell PE, de Waard AM, Holzmann MJ, Gornitzki C, Lionis C, de Wit N, Sondergaard J, Sonderlund AL, Kral N, Seifert B, Korevaar JC, Schellevis FG, Carlsson AC. Barriers and facilitators among health professionals in primary care to prevention of cardiometabolic diseases: A systematic review. Fam Pract. 2018 Jul 23;35(4):383-398. doi: 10.1093/fampra/cmx137.

    PMID: 29385438BACKGROUND
  • Nilsen P, Schildmeijer K, Ericsson C, Seing I, Birken S. Implementation of change in health care in Sweden: a qualitative study of professionals' change responses. Implement Sci. 2019 May 14;14(1):51. doi: 10.1186/s13012-019-0902-6.

    PMID: 31088483BACKGROUND
  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PMID: 28851459BACKGROUND
  • Elf M, Nordmark S, Lyhagen J, Lindberg I, Finch T, Aberg AC. The Swedish version of the Normalization Process Theory Measure S-NoMAD: translation, adaptation, and pilot testing. Implement Sci. 2018 Dec 4;13(1):146. doi: 10.1186/s13012-018-0835-5.

    PMID: 30509289BACKGROUND
  • Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

    PMID: 19664226BACKGROUND
  • Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

    PMID: 10474547BACKGROUND
  • Nilsagard YE, Smith DR, Soderqvist F, Strid EN, Wallin L. Achieving health-promotion practice in primary care using a multifaceted implementation strategy: a non-randomized parallel group study. Implement Sci Commun. 2025 Apr 7;6(1):36. doi: 10.1186/s43058-025-00723-y.

  • Nilsing Strid E, Wallin L, Nilsagard Y. Exploring expectations and readiness for healthy lifestyle promotion in Swedish primary health care: a qualitative analysis of managers, facilitators, and professionals. Scand J Prim Health Care. 2024 Mar;42(1):201-213. doi: 10.1080/02813432.2023.2301556. Epub 2024 Feb 7.

  • Strid EN, Wallin L, Nilsagard Y. Expectations on implementation of a health promotion practice using individually targeted lifestyle interventions in primary health care: a qualitative study. BMC Prim Care. 2023 Jun 16;24(1):122. doi: 10.1186/s12875-023-02079-5.

  • Strid EN, Wallin L, Nilsagard Y. Implementation of a Health Promotion Practice Using Individually Targeted Lifestyle Interventions in Primary Health Care: Protocol for the "Act in Time" Mixed Methods Process Evaluation Study. JMIR Res Protoc. 2022 Aug 19;11(8):e37634. doi: 10.2196/37634.

MeSH Terms

Conditions

Behavior

Study Officials

  • Ylva Nilsagård

    University Health Care Research Center, Region Örebro County

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A pre-post-intervention design with control group will be used to evaluate intervention uptake and implementation process effectiveness from the perspective of managers, primary care professionals, patients, and organisation. Primary care settings in central Sweden will be supported in implementing a guideline-based health-promoting way of working including screening of life-style habits, measures taken according to evidence based recommendations and documentation. Strategies will include interactive education sessions, external and internal facilitators, audit and feedback, and tools from theories of leading change; tailored according to contextual and participant needs.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 16, 2021

Study Start

March 30, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

We don't collect individual data other than in the qualitative parts and we don't have ethical approval to share that

Locations