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Self-management Intervention for People With Cardiometabolic Multimorbidity: A Pilot Randomized Controlled Trial

2 september 2026 bijgewerkt door: Rui She, The Hong Kong Polytechnic University

A Multi-faceted Self-management Intervention for Improving Patient Activation and Lifestyle Behavior Modification Among People With Cardiometabolic Multimorbidity: A Pilot Randomized Controlled Trial

This pilot randomized controlled trial aims to evaluate the feasibility and preliminary effects of a telephone-based self-management intervention for adults with cardiometabolic multimorbidity. Cardiometabolic multimorbidity refers to having two or more chronic cardiometabolic conditions, such as hypertension, type 2 diabetes, hyperlipidemia, metabolic syndrome, coronary heart disease, or stroke.

The intervention integrates motivational interviewing, self-affirmation, and problem-solving training to support participants in improving their motivation, confidence, and skills for chronic disease self-management and lifestyle behavior modification.

Participants will be randomly assigned to either the intervention group or the usual care group. The intervention group will receive two biweekly telephone consultation sessions. The control group will receive usual care according to government guidelines. All participants will complete assessments at baseline, immediately after the intervention, and 3 months after the intervention.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

72

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • aged ≥18 years
  • having at least two chronic cardiometabolic diseases (i.e., hypertension, type 2 diabetes, hyperlipidemia, metabolic syndrome, coronary heart disease, or stroke) as confirmed by a doctor or the use of corresponding prescription medications/treatment
  • having mobile phones
  • mentally competent to understand the study.

Exclusion Criteria:

  • current participation in similar projects or serious or life-threatening medical conditions (e.g., cancer, end-stage renal disease with dialysis, dementia) that would hinder study procedures.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: MSP-MI
The intervention will comprise two biweekly telephone consultations, conducted by well-trained RAs with expertise in social science, health psychology, or behavioral medicine. These consultations will utilize MI blended with behavioral change techniques, including self-affirmation and problem-solving training.
Gedragsmatig: Motivational interviewing, self-affirmation and problem-solving
The proposed study will use an MI-based intervention, blended and strengthened by self-affirmation and problem-solving techniques (MSP-SMI) to improve patient activation and lifestyle modification in patients with multimorbidity in HK. This integrated intervention is designed to tackle key behavioral change processes as posited in the IMB model and thus may have enhanced efficacy.
Andere namen:
  • motiverende gespreksvoering
  • probleemoplossing
  • zelfbevestiging
  • MSP-MI
Placebo-vergelijker: Usual care
The control group will receive usual care accordingly to government guidelines.
Ander: Usual Care
The control group will receive usual care accordingly to government guidelines.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Retention rate at 3 months
Tijdsspanne: From randomization to the end of intervention at 3 months
Proportion of randomized participants who complete the 3-month primary assessment
From randomization to the end of intervention at 3 months
Intervention adherence rate
Tijdsspanne: From enrollment to the end of intervention
Proportion of participants who attend all the scheduled intervention sessions
From enrollment to the end of intervention
Recruitment rate
Tijdsspanne: From the start of recruitment to completion of enrollment
Proportion of eligible individuals who consent and are randomized.
From the start of recruitment to completion of enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in mental health from baseline to 3 months
Tijdsspanne: From baseline to the end of intervention at 3 months
Mental health will be assessed using the Patient Health Questionnaire-4, with higher scores indicating greater mental distress.
From baseline to the end of intervention at 3 months
Change in patient activation from baseline to 3 months
Tijdsspanne: From baseline to the end of intervention at 3 months
Patient activation will be assessed using the 13-item Patient Activation Measure. The PAM-13 consists of 13 items on a 4-point Likert scale. Item scores are summed up to a raw sum score resulting in theoretical values between 13 and 52, which are then transformed to a standardized metric ranging from 0 to 100. Higher scores indicate greater patient activation.
From baseline to the end of intervention at 3 months
Change in health behavior from baseline to 3 months
Tijdsspanne: From baseline to the end of intervention at 3 months
Health behavior will be assessed using the 12-item Simple Lifestyle Indicator Questionnaire. The SLIQ has 5 components: diet (3 questions), activity (3 questions), alcohol consumption (3 questions), smoking (2 questions), and stress (1 question). For each component, a raw score and a category score can be calculated. To provide equal weighting for each component, the overall SLIQ score is based on the 5 category scores. Each component has a category score of 0, 1, or 2, so overall SLIQ scores can range from 0 to 10. The higher the score, the healthier the lifestyle.
From baseline to the end of intervention at 3 months
Change in motivation for behavior change from baseline to 3 months
Tijdsspanne: From baseline to the end of intervention at 3 months
Motivation for behavior change will be assessed using the Contemplation Ladder. It displays a picture of a ladder numbered from 0 to 10. Higher scores indicate greater readiness or motivation to change health behavior.
From baseline to the end of intervention at 3 months
Change in self-efficacy for managing chronic disease from baseline to 3 months
Tijdsspanne: From baseline to the end of intervention at 3 months
Self-efficacy for managing chronic disease will be assessed using the six-item Self-Efficacy for Managing Chronic Disease Scale. It has a 10-point Likert-type scoring system (1 = Not at all confident, 10 = Totally confident). The total scores range from 6 to 60, with higher scores indicating greater self-efficacy.
From baseline to the end of intervention at 3 months
Change in health-related quality of life from baseline to 3 months
Tijdsspanne: From baseline to the end of intervention at 3 months
Health-related quality of life will be assessed using the 5 levels of severity for each of the 5 dimensions from the EuroQoL Group (EQ-5D-5L), which consists of 2 parts: the EQ-5D and EQ visual analog scale. The EQ-5D-5L utility index score will be calculated using the value set of the appropriate population (typically range from less than 0 up to 1 for full health), with higher scores indicating better health-related quality of life.
From baseline to the end of intervention at 3 months
Change in self-rated health status from baseline to 3 months
Tijdsspanne: From baseline to the end of intervention at 3 months
Self-rated health status will be assessed using the EQ visual analog scale of 5 levels of severity for each of the 5 dimensions from the EuroQoL Group (EQ-5D-3L). Scores range from 0 to 100, with higher scores indicating better self-rated health.
From baseline to the end of intervention at 3 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Qualitative process evaluation of intervention feasibility and acceptability
Tijdsspanne: From enrollment to the end of intervention at 3 months
Approximately 20-30 participants will be invited to participate in semi-structured interviews, or until thematic saturation is reached. Interviews will explore participants' experiences, perceived feasibility, acceptability, barriers, and facilitators related to the intervention. Qualitative data will be audio-recorded, transcribed, and analyzed thematically. Findings will be reported narratively and will not be aggregated into a single quantitative score.
From enrollment to the end of intervention at 3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Hong Kong Polytechnic University

Onderzoekers

  • Hoofdonderzoeker: rui she, PhD, The Hong Kong Polytechnic University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

31 augustus 2026

Primaire voltooiing (Geschat)

31 oktober 2027

Studie voltooiing (Geschat)

31 oktober 2027

Studieregistratiedata

Eerst ingediend

10 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 augustus 2026

Eerst geplaatst (Werkelijk)

28 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Ref. 22231741

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

he data sharing plan has not yet been finalized and will be determined in accordance with participant consent, institutional policies, and ethics approval requirements.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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