Testing the Effect of KnowMAP (Knowledge Management for Renal Transplant Recipients). A Randomized Controlled Study

NCT04296955 | Active Not Recruiting

• 1 other identifier: 29385
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled study (RCT) aiming to test the effect of a new health literacy intervention for renal transplant recipients, KnowMAP (knowledge management for renal transplant recipients).

Conditions

Kidney Transplantation

Keywords

health literacy; motivational interview; adherence; organ transplantation

Outcome Measures

Primary Outcomes (2)

• Health literacy (HL)

  HL measured by the HLQ (Health Literacy Questionnaire): The HLQ includes 44 items over nine independent scales, each representing a different element of the overall HL construct. Each scale includes 4-6 items. The first five scales comprise items asking the respondents to indicate level of agreement \[ranging from strongly disagree to strongly agree (range 1-4)\]. The remaining scales (6-9) have domains of self-reported capability (range 1-5: 'cannot do' to 'very easy'). The questionnaire has no total score, as that could potentially mask individual needs in specific HL domains. The HLQ appears robust for its intended purpose of assessing HL in a range of settings and has shown excellent reliability.

  24 months post transplantation

• Adherence to immunosuppressive medication

  The instrument BAASIS (The BAsel Adherence to immunoSuppressIve medication Scale) a self reporting adherence questionnaire measuring patients' taking, skipping, timing (\>2 hrs from prescribed time) and dose reduction of drugs. The recall period is limited to four weeks. The BAASIS comprises four questions with a 6-point scale for responses ranging from never (0) to every day (5)

  24 months post transplantation

Secondary Outcomes (3)

• Quality of life and cost-effectiveness estimates relevant to this clinical context

  24 months post transplantation

• Knowledge

  24 months post transplantation

• Occations of graft loss

  24 months post transplantation

Study Arms (2)

Health communication intervention

EXPERIMENTAL

Motivational interview as a new health communication intervention (one arm)

Other: Motivational interview as a new health communication intervention

Standard care

NO INTERVENTION

Standard care

Interventions

Motivational interview as a new health communication intervention OTHER

Same as intervention name

Health communication intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplanted patients \> 18 years included within few days after kidney transplantation at Oslo University Hospital
• Able to speak and understand Norwegian

You may not qualify if:

• Not able to speak or understand Norwegian well enough to be able to fill out forms or have a conversation in Norwegian.
• Kidney transplanted patient \<18 years

Sponsors & Collaborators

• Oslo University Hospital: lead
• Helse Sor-Ost: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andersen

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Block randomization
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Model Details: Interventional study model: Parallel assignment. 2- arm un-blinded RCT design. The arms are: 1. The intervention: 4 individual patient counseling sessions using adapted motivational interviewing techniques in addition to usual care. 2. Usual care: patients undergo standard patient education program for renal transplant recipients at OUS.

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: March 9, 2020
• Primary Completion: June 15, 2021
• Study Completion: October 31, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

NO (1)