Comparing Sarcopenia , Physical, Psychological and Social Frailty in Hospitalized Older Women Congestive Heart Failure in Metropolitan and Rural Settings

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 65 years and older
• All sexes
• No healthy volunteers
• Older adult

About this study

Official title: Comparing Sarcopenia, Physical, Psychological and Social Frailty in Hospitalized Older Women Congestive Heart Failure (CHF) in Metropolitan and Rural Settings: a 3-Year Longitudinal Study Incorporating Information and Communication Technology (ICT) Interventions.

Conditions

65 Years Older, CHF - Congestive Heart Failure, Social Communication, Sarcopenia in Elderly

Being tested

ChatGPT, community social

Keywords

Frailty, Sarcopenia, Social Frailty, Congestive Heart Failure, Older Women, ICT Intervention, Metropolitan, Rural

Medical subject headings

Heart Failure, Communication, Frailty, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• ChatGPTBehavioural

  Phase 3:In Experimental Group 1, participants will be invited to use the ICT app, which they are encouraged to engage with for at least 15 minutes daily. This app is designed to actively monitor the users' emotional status and automatically notify both the research team and family members if any negative mood is detected.

• community socialBehavioural

  Phase 3:In Experimental Group 2, participants will be encouraged to increase their social participation through community-based activities, while the Control Group will continue with their routine lifestyle.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Tilburg Frailty Indicator (TFI)

   Assesses multidimensional frailty across physical, psychological, and social domains using a 15-item questionnaire. It consists of two parts: the first part gathers data on determinants of frailty (e.g., age, gender, marital status), while the second part includes 15 items divided into physical (8 items), psychological (4 items), and social (3 items) domains. This instrument offers a holistic view of an individual's frailty status. The TFI has shown good internal consistency (Cronbach's α = 0.79) and predictive validity for adverse outcomes, including functional decline and mortality.

   Score range : 0-15 Scores 0-4 Scores: non-frail ; 5 Scores or more: frail

   Measured: Baseline, 3-month follow-up

2. Makizako Social Frailty Index

   Assesses social frailty through a set of 5 questions related to social participation, activities, and support networks. The questionnaire has demonstrated good test-retest reliability and criterion validity in predicting adverse health outcomes such as reduced physical activity and functional decline. These instruments collectively provide a comprehensive framework for assessing physical, psychological, and social frailty, especially in studies involving older adults.

   Score range : 0-5 Scores 0 Scores: non-Social Frailty ;

   1. Scores : Pre-Social Frailty ;
   2. Scores or more: Social Frailty

   Measured: Baseline, 3-month follow-up

3. International Physical Activity Questionnaire - Short Form (IPAQ-S)

   A self-reported measure assessing physical activity over the last seven days. It categorizes activity levels based on frequency and intensity, covering domains such as walking, moderate activity, and vigorous activity.

   Calculate MET-minutes/week Category 1: Low No activity is reported \& Activity does not meet the criteria for Moderate or High categories.

   Category 2: Moderate

   Meets any of the following:

   3 or more days of vigorous activity of at least 20 min/day ; 5 or more days of moderate activity and/or walking of at least 30 min/day ; 5 or more days of any combination of walking, moderate, or vigorous activities, achieving at least 600 MET-min/week Category 3: Vigorous

   Meets either of the following:

   At least 3 days, accumulating at least 1500 MET-min/week, OR 7 or more days of any combination of activities totaling ≥3000 MET-min/week

   Measured: Baseline, 3-month follow-up

4. Minnesota Living with Heart Failure Questionnaire（MLHFQ）

   One of the most widely used health-related quality of life questionnaires for patients with CHF.

   Score range : 0-105 Scores 0-24 Scores: Low impact of heart failure on life ; 25-45 Scores: Moderate impact of heart failure on life ; 46 Scores or more: Serious impact of heart failure on life

   Measured: Baseline, 3-month follow-up

5. UCLA Loneliness Scale

   Measures subjective feelings of loneliness and social isolation. Score range : 6-18 Scores ; Higher total scores indicate greater feelings of loneliness.

   Measured: Baseline, 3-month follow-up

6. Geriatric Depression Scale (GDS-15)

   A shorter 15-item version and designed to screen for depression in older adults.

   Each depressive answer scores 1 point. Some items count "Yes" as a point. Some items count "No" as a point. The maximum total score is 15. Items Scored as 1 Point for a "Yes" Answer:1, 5, 7, 11, 13 Items Scored as 1 Point for a "No" Answer:2, 3, 4, 6, 8, 9, 10, 12, 14, 15 Interpretation of Scores 0-6: Normal (no depression) ; 7-10: Moderate depression ; 11-15: Severe depression

   Measured: Baseline, 3-month follow-up

7. Clinical Frailty Scale (CFS)

   A 9-point scale that evaluates an individual's level of frailty based on their physical functioning and overall health status.

   Scoring Range The scale ranges from 1 to 9, with higher scores indicating greater frailty.

   Measured: Baseline, 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Aug 2025
2. Study start1 Sep 2025 (estimated)
3. Primary completion31 Jul 2028 (estimated)
4. Study completion31 Jul 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for 65 Years OlderStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.