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Not yet recruiting NCT06919575

A Individualized Physical Function Improvement Program for Frailty Elderly Using Goal Attainment Scaling (GAS) as Evaluation Method: Protocol for a Randomized Controlled Trial

No phase Interventional Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multicomponent frailty intervention.
Who it may be relevant to
Registry conditions: Elderly. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Frailty refers to the age-related decline in physiological functions,that is associated with adverse outcomes. Frailty is a dynamic reversible state, that requires a comprehensive individualized management. Goal Attainment Scaling (GAS) is a structured, individualized method for setting and evaluating progress toward personalized goals. We conducted a randomized clinical trial of an individualized intervention program using GAS as evaluation method designed to improve physical functional in frailty elderly. A total of 160 individuals aged ≥60 years, who fulfill the Fried scale of frailty will be recruited from Beijing Chaoyang Hospital, Capital Medical University. All participants set personalized goals through GAS. Patients in the intervention group receive individualized interventions, implement tailored measures based on personalized goals to reverse the frailty state.The participants will be followed-up for 3 months and 24 months. This protocol would be established to examine the efficiency of targeted individualized intervention for frailty based on the GAS. If a positive consequence could be obtained, the results of this study will provide critical data for management of frailty in the elderly, that can be carried out in routine clinical practice.

Interventions

  • Combination product Multicomponent frailty intervention
    First, the underlying causes of the patient's frailty should be analyzed. Individualized goals should be established using Goal Attainment Scaling (GAS), followed by implementation of tailored measures. For patients presenting with malnutrition or mood-related disorders, comprehensive nutritional and psychological assessments must be conducted, with subsequent nutritional support or pharmacological treatment initiated when clinically indicated. The patients of the intervention group with poor p

Primary outcome measures

  • Goal Attainment Scaling (GAS) Formulation of intervention objectives and attainment of goals was assessed using the Goal Attainment Scaling (GAS). GAS is a structured, individualized method for setting and evaluating progress toward personalized goals. [Time frame: The GAS score was calculated according to a standardized formula and assessed at baseline, 3 months, and 24 months.]

Eligibility criteria

The inclusion criteria were the following: (1)≥60-years old; (2) recognized as frailty by Fried scale.

The exclusion criteria were the following: (1) considered with life expectancy < 1 year such as advanced cancer patients; (2) difficult to communicate with such as patients with severe cognitive impairment (Mini Mental State Examination score ≤ 17); (3) severe hearing disord.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Kang Y, Qi ZC, Guo MT, Wang XJ. An individualized physical function improvement program for frailty elderly using goal attainment scaling (GAS) as evaluation method: protocol for a randomized controlled trial. BMC Geriatr. 2025 Jul 15;25(1):528. doi: 10.1186/s12877-025-06203-1. PMID 40665225

Identifiers

NCT: NCT06919575 · CYYY-Frailty-GAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗