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

2 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

72

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Hong Kong
      • Hong Kong, Hong Kong, Kina

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Andra namn:
  • motiverande intervju
  • problemlösning
  • självbekräftelse
  • MSP-MI
Placebo-jämförare: Usual care
The control group will receive usual care accordingly to government guidelines.
Övrig: Usual Care
The control group will receive usual care accordingly to government guidelines.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Retention rate at 3 months
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in mental health from baseline to 3 months
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Qualitative process evaluation of intervention feasibility and acceptability
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Hong Kong Polytechnic University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

31 augusti 2026

Primärt slutförande (Beräknad)

31 oktober 2027

Avslutad studie (Beräknad)

31 oktober 2027

Studieregistreringsdatum

Först inskickad

10 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

25 augusti 2026

Första postat (Faktisk)

28 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Ref. 22231741

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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